BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMEDICS

    MDR report key: 827789 · Received February 27, 2007

    Report

    Report Number
    1832894-2006-00009
    Event Type
    Injury
    Date Received
    February 27, 2007
    Date of Event
    March 5, 2006
    Report Date
    December 22, 2006
    Manufacturer
    HOMEDICS, INC., US AGENT FOR TEAMEDICS
    Product Code
    IRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESPONSE TO 483 FOR INSPECTION 12/2006. CO DID NOT DISTRIBUTE HEATING PADS TO WALGREENS UNTIL 2001. THE CUSTOMER CLAIMS SHE PURCHASED HEATING PAD FROM WALGREENS IN 1999. THIS IS NOT A CO HEATING PAD.

    Description of Event or Problem · 1

    CONSUMER ALLEGES SHE RECEIVED 2ND DEGREE BURNS ON HER BACK AND HIPS FROM THE HEATING PAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMEDICS HEATING PAD IRT HOMEDICS, INC., US AGENT FOR TEAMEDICS HP-150 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other