BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERABATH PARAFFIN THERAPY BATH

    MDR report key: 2163292 · Received July 11, 2011

    Report

    Report Number
    2163292
    Event Type
    Malfunction
    Date Received
    July 11, 2011
    Date of Event
    March 2, 2011
    Report Date
    July 11, 2011
    Manufacturer
    WR MEDICAL ELECTRONICS
    Product Code
    IMC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SD, US

    Narratives

    Description of Event or Problem · 1

    A PATIENT WAS USING THE PARAFFIN WAX MACHINE AND DEVELOPED A BURN ON DISTAL TIP OF MIDDLE FINGER OF RIGHT HAND. THE THERAPIST CHECKED THE BOTTOM ON THE INSIDE OF THE MACHINE AND IDENTIFIED THAT THERE WERE SEVERAL HOT SPOTS ON THE EDGES ALONG THE BASE (THE WAX WAS NOT TOO HOT). THE BURN WAS A VERY SMALL BLISTER WHICH DID NOT REQUIRE ANY TREATMENT. TEN DAYS AFTER THE OCCURRENCE, A FOLLOW UP CALL ELICITED THE INFORMATION FROM THE PATIENT THAT ALL WAS FINE AND HIS FINGER WAS HEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERABATH PARAFFIN THERAPY BATH PARAFFIN WAX BATH IMC WR MEDICAL ELECTRONICS 50 - 60 HZ MODEL TB5 *

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR