BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK

    MDR report key: 216374 · Received March 25, 1999

    Report

    Report Number
    MW1015994
    Event Type
    Malfunction
    Date Received
    March 25, 1999
    Date of Event
    March 11, 1999
    Report Date
    March 24, 1999
    Manufacturer
    UNK
    Product Code
    FTR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BILATERAL BREAST IMPLANTS RUPTURED REQUIRING EXPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK Implant BI-LATERAL BREAST IMPLANTS FTR UNK * *

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other