BEUDAMED
    FDA Adverse Event Other Summary report: N

    METAL PLATE AND SCREW

    MDR report key: 19138 · Received January 25, 1995

    Report

    Report Number
    MW1004866
    Event Type
    Other
    Date Received
    January 25, 1995
    Report Date
    January 12, 1994
    Manufacturer
    UNKNOWN
    Product Code
    MCV
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR HAS NOT BEEN RELIEVED OF PAIN SINCE SURGERY. SHE HAS HAD NUMBNESS IN BOTH LEGS, SO SEVERE SHE FELL TO THE FLOOR AND COULDN'T GET UP FOR AN HOUR. SHE WETS HERSELF ON OCCASION, NOT EVEN HAVING THE SENSATION TO URINATE. HER BACK (RIGHT SIDE MOSTLY) STAYS SORE TO TOUCH. SHE HAS LOTS OF PAIN, AND CONSTANT BACKACHES. SHE HURTS FOR TWO DAYS AFTER SEX. SHE DOES NOT FEEL ANY BETTER SINCE SURGERY, MAY BE EVEN WORSE. SHE REQUESTED A TENS UNIT TO HELP WITH PAIN SO SHE CAN WORK AN 8-HR DAY. SHE TAKES LODINE AND AMITRIPTYLINE FOR INFLAMMATION AND PAIN. SHE CANNOT STOP SMOKING. WHEN SHE IS HURTING SHE "PULLS" CIGARETTES. DR DID MYELOGRAM IN 12/94 AND FEELS HE NEEDS TO REMOVE THE DEVICES, HOPEFULLY TO CORRECT HER PROBLEMS. DR FOUND BULGE IN S-1, DIDN'T SEEM CONCERNED ABOUT THIS, JUST IN TAKING OUT DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 METAL PLATE AND SCREW Implant METAL PLATE AND SCREW MCV UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other