BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARABATH

    MDR report key: 1980053 · Received February 1, 2011

    Report

    Report Number
    MW5019244
    Event Type
    Malfunction
    Date Received
    February 1, 2011
    Date of Event
    January 22, 2011
    Report Date
    February 1, 2011
    Manufacturer
    HYGENIC CORP
    Product Code
    IMC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ELECTRIC PARAFFIN BATH THERMOSTAT NOT WORKING CORRECTLY CAUSING TEMP TO BE TOO HOT. DATES OF USE: (B)(6) 1998 - (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARABATH PARABATH IMC HYGENIC CORP 5/N944691

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR