BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 1980027 · Received January 31, 2011

    Report

    Report Number
    MW5019237
    Event Type
    Injury
    Date Received
    January 31, 2011
    Date of Event
    January 10, 2011
    Report Date
    January 31, 2011
    Manufacturer
    UNK
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    LEFT BREAST CAPSULECTOMY WITH IMPLANT EXCHANGE AND REMOVAL OF BREAST IMPLANT MATERIAL ON (B)(6) 2011. LEFT BREAST IMPLANT WAS FOUND TO BE RUPTURED AT TIME OF SURGERY. UNK WHEN AND WHO WITH LEFT BREAST IMPLANT. IMPLANT HANDED OFF THE SURGICAL FIELD FOR EVAL BY MFR. GIVEN TO PLASTIC SURGEON FOR WORK WITH COMPANY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN BREAST IMPLANT FWM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization