BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNK

    MDR report key: 186996 · Received September 9, 1998

    Report

    Report Number
    186996
    Event Type
    Other
    Date Received
    September 9, 1998
    Date of Event
    September 2, 1998
    Report Date
    September 3, 1998
    Manufacturer
    NA
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NV, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BILATERAL CAPSULAR CONTRACTURE AND RUPTURE OF BREAST IMPLANTS WHICH REQUIRED BILATERAL CAPSULECTOMIES AND BILATERAL REMOVAL AND REPLACEMENT OF BREAST IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK Implant SILICONE BREAST IMPLANTS FTR NA UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other