BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 490703 · Received September 22, 2003

    Report

    Report Number
    MW1029803
    Event Type
    Injury
    Date Received
    September 22, 2003
    Date of Event
    April 1, 1990
    Report Date
    September 22, 2003
    Manufacturer
    MENTOR
    Product Code
    FAF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT RECEIVED A SILICONE TESTICULAR DEVICE AFTER APPARENTLY SUCCESSFUL REMOVAL OF A TESTICULAR TUMOR. A YEAR LATER THEY BEGAN TO HAVE MYALGIAS AND TRANSIENT MUSCULAR WEAKNESS BOTH OF WHICH HAVE CONTINUED TO DATE AND WHICH BECAME WORSE AND MORE WIDESPREAD, TO THE POINT OF HAVING TO GIVE UP THEIR GOAL OF LONG DISTANCE RUNNING. THERE IS NO FAMILY HISTORY OF MUSCLE DISEASE. THE DEVICE WAS REMOVED IN 1994 WITH ONLY TEMPORARY RELIEF OF THEIR PROGRESSIVE DISABILITY. THE DIAGNOSIS OF ERYTHROMELALGIA WAS CONSIDERED (ARCH.DERMATOL, 136:330-336, 2000] IN ADDITION TO SILICONE TOXICITY [J.NUTRI.ENVIRON.MED.12:101-106,2002]. PT HAS RESPONDED TEMPORARILY TO HIGH DOSES OF INOSITOL AND SHORT TERM COURSES OF HYDROXY-CHLOROQUINE, THE LATTER POSSIBLY BUT NOT YET PROVEN TO HAVE BEEN THE REASON FOR A SKIN RASH IN JUNE 2003, PROMPTING STOPPING THE DRUG. SEVERE FATIGUE PERSISTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * SOLID SILICONE TESTICULAR DEVICE FAF MENTOR * *

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Life Threatening| O| R| S