BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTHEAT

    MDR report key: 2142407 · Received June 21, 2011

    Report

    Report Number
    1314800-2011-00026
    Event Type
    Injury
    Date Received
    June 21, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 7, 2011
    Manufacturer
    KAZ INC
    Product Code
    IRT
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER REPORTED CUTTING HER EYE ON THE EDGE OF THE HEATING PAD. SHE WAS PICKING UP THE UNIT AND IT HIT HER IN THE EYE CAUSING A CUT TO HER EYE LID AND CORNEA. SHE DID SEEK MEDICAL ATTENTION AND WAS PRESCRIBED ANTIBIOTICS DROPS FOR THE INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTHEAT HEATING PAD IRT KAZ INC HP215 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other