BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIP, INC

    MDR report key: 217101 · Received April 1, 1999

    Report

    Report Number
    1062078-1999-00042
    Event Type
    Malfunction
    Date Received
    April 1, 1999
    Date of Event
    March 3, 1999
    Report Date
    March 8, 1999
    Manufacturer
    PIP, INC
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DEFLATION OF THE RIGHT BREAST IMPLANT, REASON UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIP, INC Implant BREAST IMPLANT FWM PIP, INC TEXTURED 97257

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other