BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIP, INC.

    MDR report key: 229727 · Received June 28, 1999

    Report

    Report Number
    1062078-1999-00148
    Event Type
    Malfunction
    Date Received
    June 28, 1999
    Date of Event
    May 20, 1999
    Report Date
    June 14, 1999
    Manufacturer
    PIP, INC.
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DEFLATED IMPLANT, RIGHT SIDE. REASON UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIP, INC. Implant BREAST IMPLANT FWM PIP, INC. TEXTURED 96113

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other