BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BESMED

    MDR report key: 439228 · Received January 6, 2003

    Report

    Report Number
    MW4003443
    Event Type
    Injury
    Date Received
    January 6, 2003
    Date of Event
    September 1, 2001
    Manufacturer
    MULTINATIONAL MNE (FAIR SHOWS #6)
    Product Code
    GZJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CONSUMER PURCHASED THE BESMED UNIT IN 2001. IT IS AN ELECTRICAL SHOCK UNIT THAT IS DESIGNED TO AID IN MUSCLE SPASM AND PAIN. CONSUMER WAS USING IT ON THEIR LOWER BACK AS DIRECTED. THEY THEN BEGAN TO HAVE GROSS HEMATURIA. CONSUMER WAS SEEN AT THE HOSPITAL EMERGENCY ROOM AND FROM THERE THEY WERE REFERRED TO A UROLOGIST. THE UROLOGIST DID PERFORM SURGERY AND MULTIPLE LAB TESTS TO DIAGNOSIS AND CORRECT THE PROBLEM. NEITHER OF THE PHYSICIANS THEY SAW WERE ABLE TO RULE OUT THE BESMED UNIT AS THE CAUSE. CONSUMER DOES HAVE LAB REPORTS, DOCTOR RECORDS, AND THE EMERGENCY ROOM REPORT VERIFYING THIS. THE BUSINESS HAS REFUNDED THEIR MONEY IN FULL. THEY ARE SEEKING TO MAKE THE ATTORNEY GENERALS OFFICE AND OTHER POTENTIAL CUSTOMERS AWARE OF THE DANGERS AND MEDICAL RISKS OF USING THIS PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BESMED ELECTRICAL SHOCK UNIT GZJ MULTINATIONAL MNE (FAIR SHOWS #6) * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *