BEUDAMED
    FDA Adverse Event Summary report: N

    MENTOR WORLDWIDE LLC

    MDR report key: 1851733 · Received September 24, 2010

    Report

    Report Number
    1645337-2010-00026
    Date Received
    September 24, 2010
    Date of Event
    September 8, 2010
    Report Date
    September 23, 2010
    Manufacturer
    MENTOR WORLDWIDE LLC
    Product Code
    FTR
    PMA / PMN Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SILICONE GEL IS EXCRETING FROM PATIENT'S SKIN THROUGH HER PORES, ALL OVER HER ENTIRE BODY. PER DOCTOR'S NOTES: TWO YEARS AGO WE DID A BREAST AUG ON HER AND SHE NOTICED A RASH 9 MONTHS AGO. SHE NOTICED LITTLE FLECKS. SHE FIRST WENT TO A DERMATOLOGIST IN (B)(6) AND SHE SAW 3 OR 4 AND THEY REFERRED HER TO THE (B)(6) AND THEY IMMEDIATELY SENT HER TO (B)(6). SHE WAS UP THERE FOR A MONTH AND SHE WAS ON STEROIDS AND CREAMS AND OINTMENT AND THEY DID EVERY TEST. THEY DID BIOPSIES AND SHE SAID NOTHING EVER SHOWED UP. PT CAME IN THINKING SHE HAD A RUPTURE RIGHT IMPLANT. MRI CONFIRMS NO INTRACAPSULAR OR EXTRACAPSULAR RUPTURE. LAB RESULTS APPEAR WITHIN NORMAL RANGE. AMERIPATH'S REPORT READS: "SOFT CLEAR FOREIGN DEBRIS COMPATIBLE WITH SILICONE, NOT DIAGNOSTIC." PT CLAIMS SHE HAS HAD NO SILICONE INJECTIONS OF ANY KIND. THE IMPLANTS WERE FOUND TO BE INTACT UPON REMOVAL. NOT EVEN GEL BLEED WAS OBSERVED. A LOT SEARCH WAS PERFORMED IN (B)(4) DATABASE AND THERE ARE NO OTHER COMPLAINT OF THIS TYPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MENTOR WORLDWIDE LLC GEL-FILLED MAMMARY PROSTHESIS FTR MENTOR WORLDWIDE LLC 5782534

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR