BEUDAMED
    FDA Adverse Event Other Summary report: N

    PIP, INC.

    MDR report key: 220943 · Received April 8, 1999

    Report

    Report Number
    9681903-1999-00033
    Event Type
    Other
    Date Received
    April 8, 1999
    Date of Event
    July 30, 1998
    Report Date
    February 23, 1999
    Manufacturer
    PIP, INC.
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CAPSULAR CONTRACTURE OF THE RIGHT BREAST IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIP, INC. Implant BREAST IMPLANT FWM PIP, INC. SMOOTH 97104

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other