BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIND + BODY CARE

    MDR report key: 9569752 · Received January 9, 2020

    Report

    Report Number
    1314800-2020-00003
    Event Type
    Injury
    Date Received
    January 9, 2020
    Report Date
    February 10, 2020
    Manufacturer
    KAZ USA, INC., A HELEN OF TROY COMPANY
    Product Code
    IRT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING, BUT IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    A CONSUMER STATED THAT SHE HAD ALLEGEDLY RECEIVED THIRD DEGREE BURNS ON HER SIDE WHILE USING A HEATING PAD, AND MEDICAL ATTENTION WAS LATER SOUGHT FOR HER INJURIES. THE CONSUMER STATED THAT THIS INCIDENT OCCURRED WHILE SHE WAS SLEEPING WITH THE HEATING PAD, AND SHE INITIALLY THOUGHT THAT SHE HAD SHINGLES. THE INSTRUCTIONS FOR PROPER USE CLEARLY STATE "DO NOT USE THIS WRAP WHILE SLEEPING". KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING.

    Description of Event or Problem · 1

    A CONSUMER STATED THAT SHE HAD ALLEGEDLY RECEIVED THIRD DEGREE BURNS ON HER SIDE WHILE USING A HEATING PAD, AND MEDICAL ATTENTION WAS LATER SOUGHT FOR HER INJURIES. THE CONSUMER STATED THAT THIS INCIDENT OCCURRED WHILE SHE WAS SLEEPING WITH THE HEATING PAD, AND SHE INITIALLY THOUGHT THAT SHE HAD SHINGLES. THE INSTRUCTIONS FOR PROPER USE CLEARLY STATE "DO NOT USE THIS WRAP WHILE SLEEPING".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32313 MIND + BODY CARE WRAPAROUND¿ ELECTRIC SPA WRAP IRT KAZ USA, INC., A HELEN OF TROY COMPANY HEW3000 31516GMT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R| S