BEUDAMED
    FDA Adverse Event Other Summary report: N

    NA

    MDR report key: 177933 · Received July 15, 1998

    Report

    Report Number
    177933
    Event Type
    Other
    Date Received
    July 15, 1998
    Date of Event
    July 2, 1998
    Report Date
    July 10, 1998
    Manufacturer
    NA
    Product Code
    FWM
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NV, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BILATERAL CAPSULAR CONTRACTURE REQUIRING THE REMOVAL OF BILATERAL BREAST IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA Implant SALINE BREAST IMPLANTS FWM NA NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other