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14,953 results

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Are these risks potentially serious? Date: 15. June 2021 Topics: Medical devices Type: FAQ

No, but a ruptured breast implant should be replaced. This recommendation applies to any type of breast implant.

What are the risks for my health? Date: 15. June 2021 Topics: Medical devices Type: FAQ

At this point no complications different from those usually encountered with other breast implants have been identified.
However, a higher frequency of rupture of these implants and local inflammatory reactions have been observed.

What should I do if I have one of these implants? Date: 15. June 2021 Topics: Medical devices Type: FAQ

You should make an appointment with your doctor or surgeon in order to be examined so that he/she can prescribe an appropriate examination if necessary.
We remind you that in any case, a follow-up is set up for all women with breast implants.

What if I cannot find the surgeon who performed my surgical operation? Date: 15. June 2021 Topics: Medical devices Type: FAQ

The health-care facility where you were treated has this information. It will be easier to find your medical records if you can provide information such as date of surgery, name of surgeon, etc.

How can I find out if my implant is involved? Date: 15. June 2021 Topics: Medical devices Type: FAQ

Information about the type of breast implant inserted is available in the handbook (operative record, implant card) provided by the surgeon after your operation. In case you don’t have this information, we recommend you contact the surgeon who …

What is the problem with these implants? Date: 15. June 2021 Topics: Medical devices Type: FAQ

Afssaps decided to carry out an inspection on the premises of PIP Company after vigilance reports revealed an increase in the number of declaration of implant ruptures The elements collected during this inspection showed that the implants were filled …

Which breast implants are involved with the decision? Date: 15. June 2021 Topics: Medical devices Type: FAQ

The breast implants concerned are implants pre-filled with silicone gel manufactured by the company Poly Implant Prothèse (PIP). Afssaps decided to suspend the marketing and use of such breast implants as well as to withdraw the products from the …

Urgent Field Safety Notice for ZytoChem-Plus HRP Kit, Broad Spectrum by Zytomed Systems GmbH PDF, 100KB, File does not meet accessibility standards Date: 15. June 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 10637/21

Urgent Field Safety Notice for BESA Research 7.1 September 2020 by BESA GmbH PDF, 178KB, File does not meet accessibility standards Date: 15. June 2021 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) - others
Reference 10941/21

Urgent Field Safety Notice for Centricity High Acuity Critical Care by GE HEALTHCARE INTEGRATED IT SOLUTIONS Inc PDF, 211KB, File does not meet accessibility standards Date: 15. June 2021 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 11343/21

Urgent Field Safety Notice for Affinity IV Birthing Bed by Hill-Rom Company, Inc. PDF, 502KB, File does not meet accessibility standards Date: 15. June 2021 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment - furnishings
Reference 10484/21

Urgent Field Safety Notice for INTUBE TRACHEAL TUBE, WIRE REINFORCED CUFFED, 7MM by Intersurgical Ltd. PDF, 45KB, File does not meet accessibility standards Date: 14. June 2021 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 11074/21

Urgent Field Safety Notice for Vitalio, Ingenio, Advantio, Inliven, Intua, Invive, Accolade, Proponent, Essentio, Altrua, Visionist, Valitude by Boston Scientific CRM PDF, 511KB, File does not meet accessibility standards Date: 14. June 2021 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices - cardiac pacemakers
Reference 11055/21

Urgent Field Safety Notice for Einmal-Handwaschbürste ,steril by ROESER Medical GmbH (Essen) PDF, 777KB, File does not meet accessibility standards Date: 14. June 2021 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment - cleaning / disinfection / sterilisation
Reference 11174/21

Urgent Field Safety Notice for Linear Cutter LLC by Ethicon Endo-Surgery, Inc. PDF, 339KB, File does not meet accessibility standards Date: 14. June 2021 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - general instruments
Reference 09594/21

Urgent Field Safety Notice for M8 Lead Adaptor; S. Lead Adaptor by Nevro Corp PDF, 185KB, File does not meet accessibility standards Date: 14. June 2021 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices - biostimulators
Reference 08899/21

Urgent Field Safety Notice for INTERCEPT Blood System for Plasma by Cerus Corporation PDF, 21KB, File does not meet accessibility standards Date: 14. June 2021 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - equipment for collecting blood products and peripheral stem cells
Reference 10644/21

Urgent Field Safety Notice for CODMAN BACTISEAL EVD CATHETER SET by Integra LifeSciences Corp. PDF, 426KB, File does not meet accessibility standards Date: 11. June 2021 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 16652/20

Urgent Field Safety Notice for Q-Flow by Merivaara Corporation PDF, 231KB, File does not meet accessibility standards Date: 11. June 2021 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 10979/21

Urgent Field Safety Notice for Valiant NavionTM Thoracic Stent Graft System by Medtronic Inc PDF, 169KB, File does not meet accessibility standards Date: 11. June 2021 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 03223/21

Urgent Field Safety Notice for Vapotherm Oxygen Assist Module (OAM) by Vapotherm Inc. Exeter PDF, 125KB, File does not meet accessibility standards Date: 10. June 2021 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 03137/21

Urgent Field Safety Notice for ECHELON 60 ENDOPATH STAPLER by Ethicon Endo-Surgery, LLC. PDF, 495KB, File does not meet accessibility standards Date: 10. June 2021 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - general instruments
Reference 10558/21

Urgent Field Safety Notice for Nail Insertion Sleeve, elastic T2 Tibia SPI by Stryker Trauma GmbH PDF, 185KB, File does not meet accessibility standards Date: 10. June 2021 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 09972/21

Urgent Field Safety Notice for Navelsnodd / Cordring by Wing Plast AB PDF, 538KB, File does not meet accessibility standards Date: 09. June 2021 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - gynaecology
Reference 03577/21

Urgent Field Safety Notice for Colleague; Colleague 3 by Baxter Healthcare S. (Opfikon) PDF, 697KB, File does not meet accessibility standards Date: 09. June 2021 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 05189/21

Urgent Field Safety Notice for Miami J Cervical Collar by Össur hf PDF, 220KB, File does not meet accessibility standards Date: 09. June 2021 Topics: Medical devices Type: Customer information

Product group Orthopaedic / Rehabilitation technology - orthoses
Reference 10400/21

Urgent Field Safety Notice for JELONET by Smith & Nephew Medical Ltd. PDF, 133KB, File does not meet accessibility standards Date: 09. June 2021 Topics: Medical devices Type: Customer information

Product group Dressings / Pads - dressings
Reference 10777/21

Urgent Field Safety Notice for Bulkamid Urethral Bulking System incl. Bulkamid Needle by Contura International A/S, Ferrosan A/S PDF, 98KB, File does not meet accessibility standards Date: 09. June 2021 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - syringes and cannulas
Reference 10750/21

Urgent Field Safety Notice for CT Fluoroscopy Digital Video Interface (DVI) Packa by Philips Medical Systems Nederland B.V. PDF, 3MB, File does not meet accessibility standards Date: 09. June 2021 Topics: Medical devices Type: Customer information

Product group Radiological technology - CT scanners
Reference 10736/21

Urgent Field Safety Notice for medimex Einmal-Handwaschbürste, steril by medimex GmbH PDF, 121KB, File does not meet accessibility standards Date: 09. June 2021 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment - cleaning / disinfection / sterilisation
Reference 10721/21