BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIP, INC

    MDR report key: 228161 · Received June 18, 1999

    Report

    Report Number
    1062078-1999-00143
    Event Type
    Malfunction
    Date Received
    June 18, 1999
    Date of Event
    May 24, 1999
    Report Date
    June 2, 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

    DESCRIBE EVENT OR PROBLEM: CAPSULAR CONTRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIP, INC Implant BREAST IMPLANT FWM PIP, INC SMOOTH 97102

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other