BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DICKSON PARAFFIN BATH

    MDR report key: 7571465 · Received June 5, 2018

    Report

    Report Number
    2222003-2018-00002
    Event Type
    Injury
    Date Received
    June 5, 2018
    Date of Event
    March 22, 2014
    Report Date
    February 27, 2018
    Manufacturer
    FABRICACION Y MANUFACTURAS DE MEXICO S.A. DE C.V.
    Product Code
    IMC
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE UNIT FOUND THAT THE CHASSIS HAD BEEN ENTERED BY AN UNKNOWN THIRD PARTY. WIRING CONNECTORS AND THERMOSTAT CONNECTIONS WERE FOUND TO BE MODIFIED AND NOT MEETING DEVICE SPECIFICATIONS. THE FAILURE WAS DOCUMENTED FOR TREND ANALYSIS. CREDIT WAS ISSUED TO CUSTOMER AFTER RETURN.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN ISSUE WHERE A UNIT GOT HOT AND BURNED A USER. MULTIPLE ATTEMPTS TO CONTACT THE DISTRIBUTER FAILED AND THEREFORE ADDITIONAL EVENT DETAILS COULD NOT BE OBTAINED. THE CUSTOMER THAT CONTACTED US DID NOT CLARIFY THE SEVERITY OF THE BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411142 DICKSON PARAFFIN BATH PARAFFIN THERAPY IMC FABRICACION Y MANUFACTURAS DE MEXICO S.A. DE C.V. PB-107

    Patients

    Seq Age Sex Outcome Treatment
    1 Other