BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELAXOR THERAPY DEEPKNEADING MASSAGE

    MDR report key: 141066 · Received January 2, 1998

    Report

    Report Number
    MW1012715
    Event Type
    Malfunction
    Date Received
    January 2, 1998
    Date of Event
    January 1, 1998
    Report Date
    January 2, 1998
    Manufacturer
    J.B. RESEARCH INC.
    Product Code
    ISA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE DEVICE WAS PURCHASED FOR A GIFT. HER HUSBAND WAS USING THE DEVICE ON 1/1/98 FOR THE SECOND TIME, WHEN HE BEGAN TO SMELL SOMETHING BURNING. HE JUMPED OUT OF THE CHAIR AND NOTED A SPARK FROM THE DEVICE. A HOLE WAS BURN THROUGH THE DEVICE AND INTO THE CHAIR. NO INJURIES OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RELAXOR THERAPY DEEPKNEADING MASSAGE MASSAGER (HEATED) ISA J.B. RESEARCH INC. 1001 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other