BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREAST IMPLANT

    MDR report key: 3870217 · Received June 6, 2014

    Report

    Report Number
    MW5036542
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    February 7, 2014
    Report Date
    June 5, 2014
    Manufacturer
    MENTOR
    Product Code
    FWM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    (B)(6) HAD BREAST IMPLANT INSERTED ON (B)(6) 2003 AND A REPAIR SURGERY ON (B)(6) 2004. THE SAME IMPLANTS WERE RE-USED IN THE 2004 SURGERY. ON (B)(6) 2014 SHE NOTICED ON THE MRI MAMMOGRAM DETECTION THAT THE LEFT IMPLANT WAS RUPTURED. SHE HAS HAD NUMEROUS HEALTH PROBLEMS SUCH AS FIBROMYALGIA AND INTERSTITIAL CYSTITIS SINCE THE INSERTION OF THE IMPLANTS. SHE DOES NOT KNOW WHEN THE IMPLANTS RUPTURED BECAUSE IT WAS A SILENT RUPTURE BUT HER PRIMARY CARE PHYSICIAN BELIEVES HER HEALTH PROBLEMS MAY HAVE BEEN DUE TO THE RUPTURE. LEFT IMPLANT SPECIFICATIONS IS (B)(4); LOT IS 271332 AND SN NUMBER IS (B)(4). RIGHT IMPLANT IS (B)(4); LOT IS 271332 AND SN NUMBER IS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331248 BREAST IMPLANT BREAST IMPLANT FWM MENTOR TX1837691 271332
    331249 BREAST IMPLANT BREAST IMPLANT FWM MENTOR TX1837781 271332

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other| R| S