BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIP, INC.

    MDR report key: 220266 · Received April 23, 1999

    Report

    Report Number
    1062078-1999-00071
    Event Type
    Malfunction
    Date Received
    April 23, 1999
    Date of Event
    March 15, 1999
    Report Date
    April 12, 1999
    Manufacturer
    PIP, INC.
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    RIGHT IMPLANT DEFLATED, DR NOTED A LEAK FROM TWO TINY OPENINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIP, INC. Implant BREAST IMPLANT FWM PIP, INC. TEXTURED 96158

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other