BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALGREEN'S BY HOMEDICS

    MDR report key: 1131143 · Received August 11, 2008

    Report

    Report Number
    1832894-2008-00007
    Event Type
    Malfunction
    Date Received
    August 11, 2008
    Date of Event
    April 14, 2007
    Report Date
    August 7, 2008
    Manufacturer
    TEAMEDICS MFG CO. LTD.
    Product Code
    IRT
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HP-SPARKS OR FLAMES. ON MARCH 3, 2008, HOMEDICS BECAME AWARE OF SUBROGATION CLAIM FOR FIRE DAMAGE. IT HAS BEEN CLAIMED THAT TWO HEATING PADS AND ONE ELECTRIC BLANKET WERE OPERATING AT THE TIME OF LOSS ON THE CONSUMER'S BED. IN WHICH ONE OF THE ITEMS ALLEGEDLY CAUSED A FIRE. HOMEDICS HAS NOT RECEIVED THE HEATING PAD FOR OUR EVAL. WE HAVE REQUESTED THE FIRE MARSHALL'S REPORT, SINCE THERE IS SOME DISCUSSION AND EVIDENCE THAT NONE OF THE THREE ITEMS IN QUESTION ARE ACTUALLY THE CAUSE OF THE FIRE. THE MDR IS BEING FILED 5 MONTHS AFTER THE RECEIPT OF THE COMPLAINT DUE TO THE COMPLEXITY OF THE CLAIM AND OUR ATTEMPT TO DETERMINE IF OUR PRODUCT CONTRIBUTED TO THE INCIDENT, OR JUST HAPPENED TO BE IN THE SAME PLACE AT THE SAME TIME. WE WILL CONTINUE TO INVESTIGATE, AND SEND ANY APPROPRIATE UPDATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALGREEN'S BY HOMEDICS HEATING PAD IRT TEAMEDICS MFG CO. LTD. 802857 OR 710124 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1