BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIP, INC.

    MDR report key: 220350 · Received April 23, 1999

    Report

    Report Number
    1062078-1999-00085
    Event Type
    Malfunction
    Date Received
    April 23, 1999
    Date of Event
    April 8, 1999
    Report Date
    April 20, 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

    CAPSULAR CONTRACTURE, AND EXPLANTED UNIT WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIP, INC. Implant BREAST IMPLANT FWM PIP, INC. TEXTURED 97035

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other