BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MENTOR 3542670 BREAST IMPLANT

    MDR report key: 337423 · Received June 12, 2001

    Report

    Report Number
    MW1022156
    Event Type
    Malfunction
    Date Received
    June 12, 2001
    Date of Event
    May 20, 2001
    Report Date
    June 11, 2001
    Manufacturer
    MENTOR
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT AWAKENED IN AM TO FIND "FLAT" LEFT BREAST. DENIES PAIN OR SIGNS AND SYMPTOMS OF INFLAMMATION. SCHEDULED FOR REIMPLANTATION WHICH WAS COMPLETED. BREAST IMPLANT WAS RETURNED TO MENTOR CORP AS WELL AS REPORTING PAPERWORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26848 MENTOR 3542670 BREAST IMPLANT BREAST SILTEX 425CC IMPLANT FWM MENTOR SILTEX 192147

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other