BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIP, INC.

    MDR report key: 228132 · Received June 18, 1999

    Report

    Report Number
    1062078-1999-00131
    Event Type
    Malfunction
    Date Received
    June 18, 1999
    Date of Event
    April 27, 1999
    Report Date
    May 20, 1999
    Manufacturer
    PIP, INC.
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DEFLATION OF THE RIGHT IMPLANT, CAUSE OF DEFLATION UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIP, INC. Implant BREAST IMPLANT FWM PIP, INC. TEXTURED 96188

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other