BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIP BREAST IMPLANTS

    MDR report key: 399151 · Received June 5, 2002

    Report

    Report Number
    MW1025294
    Event Type
    Injury
    Date Received
    June 5, 2002
    Date of Event
    August 18, 1998
    Manufacturer
    PIP INC
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    RPTR HAS IDENTIFIED WHAT APPEARS TO BE AN UNUSUALLY HIGH RATE OF DEVICE FAILURE IN THE PIP IMPLANTS PLACED IN PTS. IN ADDITION IT APPEARS THAT PIP IS NOT HONORING ITS WARRANTY WHICH THE CO PROMISED FOR REIMBURSEMENT OF SURGICAL COSTS ENCOUNTERED AS A RESULT OF EXPLANTATION AND RE-IMPLANTATION OF DEFLATED DEVICES. RPTR HAS TRIED TO DEAL WITH THE CO BY TELEPHONE IN THE PAST AND OVER THE LAST SEVERAL MOS HAVE RECEIVED NO RESPONSE. RUPTURE ON INSERTION. NEW IMPLANT PLACED AT TIME OF SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIP BREAST IMPLANTS BREAST IMPLANT FWM PIP INC SALINE TEXTURED 98218

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention