BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMEDICS

    MDR report key: 1131144 · Received August 11, 2008

    Report

    Report Number
    1832894-2008-00006
    Event Type
    Malfunction
    Date Received
    August 11, 2008
    Date of Event
    February 25, 2008
    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

    Additional Manufacturer Narrative · 1

    CONSUMER CONTINUED TO USE THE HEATING PAD EVEN AFTER SHE THOUGHT IT WAS MALFUNCTIONING. CONSUMER HAD PLACED A TOWEL BETWEEN HERSELF AND THE HEATING PAD TO PROTECT HERSELF.

    Description of Event or Problem · 1

    BURN HOLE- UNIT. MODEL# HPM-100 UNIT APPEARS TO HAVE BURNED AND THE PLASTIC WAS CHARRED BENEATH THE PROTECTIVE FABRIC COVER. CONSUMER SUFFERED SMALL BURNS ON HER ABDOMEN. SHE DID NOT REQUIRE MEDICAL ATTENTION AND THE MARKS HAVE FADED. CONSUMER CONTINUED TO USE THE UNIT EVEN AFTER SHE THOUGHT IT WAS MALFUNCTIONING. SHE HAD PLACED A TOWEL BETWEEN HERSELF AND THE HEATING PAD FOR PROTECTION. WE ARE FILING THIS INCIDENT AS AN MDR SINCE IT IS SIMILAR TO OTHER MDR WE HAVE FILED IN THE PAST. WE HAVE BEEN WAITING FOR THE UNIT TO BE RETURNED TO THE MFR AND AN INVESTIGATION COMPLETED, BEFORE FILING AN MDR BASED ON THE MALFUNCTION OF THE PRODUCT. WE ARE FILING LATE (AFTER 5 MONTHS OF THE RECEIPT OF THE COMPLAINT) TO ENSURE THAT WE HAVE FILED ALL PRODUCT FAILURES PROPERLY, EVEN THOUGH WE HAVE NOT RECEIVED THE INVESTIGATION FROM THE MFR AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMEDICS MASSAGING HEATING PAD IRT TEAMEDICS MFG CO. LTD. HP-M100 4806

    Patients

    Seq Age Sex Outcome Treatment
    1