BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONAIR

    MDR report key: 18928353 · Received March 19, 2024

    Report

    Report Number
    1222304-2024-00006
    Event Type
    Injury
    Date Received
    March 19, 2024
    Date of Event
    February 17, 2024
    Report Date
    March 19, 2024
    Manufacturer
    CONAIR LLC.
    Product Code
    IRT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON 3/19/2024 - WE HAVE REQUESTED THE DEVICE BE RETURNED TO THE MANUFACTURER FOR AN INVESTIGATION. TO DATE, WE HAVE NOT RECEIVED THE DEVICE. ON 7/10/2024 - THE CONSUMER HAD RETURNED THE DEVICE TO THE MANUFACTURER FOR AN INVESTIGATION. THE INVESTIGATION HAS BEEN COMPLETED. BELOW IS THE MANUFACTURERS NARRATIVE: MANUFACTURERS NARRATIVE: UNIT MUST CONFORM TO UL130. TEMPERATURE TESTING WAS CONDUCTED PER UL130. THE UNIT IS PLACED BETWEEN INSULATORS TO REPRESENT WORSE CASE OF SOMEONE LAYING ON TOP OF PAD. UNIT TEMPERATURES COMPLIED WITH SAFETY STANDARDS. AS WITH ALL HEATING PADS, THE PAD IS TO BE DRAPED OVER THE BODY PART BEING TREATED, YOU CAN NOT SIT OR LAY DOWN ON HEATING PADS (AS STATED IN THE IB). LAYING ON TOP OF A HEATING PAD CAUSES ELEVATED TEMPERATURES WHEN COMPARED TO NORMAL USE. WE HAVE AN UPPER LIMIT OF 65C (150F). THESE TEMPERATURES ARE HOT ENOUGH TO CAUSE BURNS WHEN MISUSED. WHEN USED CORRECTLY THE TOP OF THE PAD SURFACE RELEASES HEAT INSTEAD OF BEING TRAPPED, PROVIDING THE USER WITH SIGNIFICANTLY LOWER TEMPERATURES. WE ALSO HAVE WARNINGS RELATED TO CHECKING TREATMENT AREA OFTEN.

    Additional Manufacturer Narrative · 0

    (B)(6) 2024 - WE HAVE REQUESTED THE DEVICE BE RETURNED TO THE MANUFACTURER FOR AN INVESTIGATION. TO DATE, WE HAVE NOT RECIEVED THE DEVICE.

    Description of Event or Problem · 0

    ON (B)(6) 2024 - THE CONSUMER CLAIMS TO HAVE RECEIVED A BURN ON HER BUTTOCKS WHILE LAYING ON THE PRODUCT. MEDICAL ATTENTION WAS NOT RECEIVED.

    Description of Event or Problem · 0

    (B)(6) 2024 - THE CONSUMER CLAIM TO HAVE RECEIVED A BURN ON HER BUTTOCKS WHILE LAYING ON THE PRODUCT. MEDICAL ATTENTION WAS NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2317708 CONAIR HEATING PAD IRT CONAIR LLC. HP07FWX

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other