BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PAINNOT

    MDR report key: 1151687 · Received September 4, 2008

    Report

    Report Number
    1528424-2008-00002
    Event Type
    Injury
    Date Received
    September 4, 2008
    Date of Event
    January 23, 2005
    Report Date
    September 4, 2008
    Manufacturer
    WEIGI INTERNATIONAL CO. LTD.
    Product Code
    IRT
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    MR. (B) (6) CONTACTED OUR CUSTOMER SERVICE ON (B) (6) 2005 AND STATED THAT HE RECEIVED 2ND DEGREE BURNS ON HIS UPPER BACK FROM THE PAINNOT HEATING PAD. HE WENT TO THE ER FOR TREATMENT, BUT WAS UNABLE TO PROVIDE MEDICAL DOCUMENTATION OF THE INCIDENT. HE RETURNED THE PRODUCT FOR A REFUND. NO FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PAINNOT HEATING PAD IRT WEIGI INTERNATIONAL CO. LTD. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| O