BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPECTRUM

    MDR report key: 17217 · Received August 18, 1994

    Report

    Report Number
    17217
    Event Type
    Other
    Date Received
    August 18, 1994
    Date of Event
    August 13, 1994
    Report Date
    August 18, 1994
    Manufacturer
    EAGLE MEDICAL, INC.
    Product Code
    GZJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ELECTRICAL BURN CAUSED BY EXPOSED ELECTRODE WIRE ON A TENS UNIT. BLISTERS HEALING WITH NO FURTHER PROBLEMS. TENS UNIT DID NOT MALFUNCTION - ELECTRODE WIRE REPAIRED AND UNIT RETURNED TO PT WITH NO FURTHER PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRUM TENS UNIT GZJ EAGLE MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other