BEUDAMED
    FDA Adverse Event Summary report: N

    BONE STIMULATOR

    MDR report key: 34426 · Received July 24, 1996

    Report

    Report Number
    MW1009557
    Date Received
    July 24, 1996
    Date of Event
    December 1, 1995
    Report Date
    July 23, 1996
    Manufacturer
    ELECTRO BIOLOGY, INC.
    Product Code
    LOE
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR WENT TO THE DR ON 12/95 AND THE DR TOLD HER THAT THE COATING WAS COMING OFF AND WOULD KILL HER RIGHT AWAY. SHE WAS NOT CONCERNED BECAUSE SHE WASN'T FEELING SICK. IN 3/96 SHE STARTED TO FEEL SICK. WHEN HER ARMS SWEAT, SHE FEELS LIKE THEY ARE BURING REALLY BAD, THAT'S WHEN SHE STARTED TO FIND MORE INFO ABOUT THE STIMULATOR. DR SAID THAT THE MAIN REASON THE SILICONE COATING CAME OFF, THE WIRE, WAS BECAUSE SHE SMOKES. SHE STATED "HOW CAN SOMETHING LIKE THIS BE APPROVED? I SMOKED FOR 20 YEARS AND HE NEVER ASKED ME ANYTHING." IN 12/95, DR WANTED PT TO SIGN A PAPER THAT STATED THAT SHE SHOULDN'T BE SMOKING." WHEN SHE ASKED HIM WHY, HE NEVER TOLD HER ANYTHING. HE SAID "WELL, I'M SORRY, I JUST ASSUMED YOU DIDN'T SMOKE." THE DEVICE IS MADE OF SILICONE "JUST LIKE BREAST IMPLANTS," AND SHE WANTS TO KNOW WHAT KIND OF TEST SHE NEEDS TO HAVE. SHE WENT TO A LAB AND THEY SAID THAT THEY DON'T DO ANY TEST FOR SILICONE. HER SYMPTOMS ARE "LIKE SOMEONE WHO HAS BREAST IMPLANTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BONE STIMULATOR BONE STIMULATOR LOE ELECTRO BIOLOGY, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR