BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONAIR

    MDR report key: 6192812 · Received December 21, 2016

    Report

    Report Number
    1222304-2016-00044
    Event Type
    Injury
    Date Received
    December 21, 2016
    Date of Event
    November 2, 2016
    Report Date
    November 29, 2016
    Manufacturer
    CONAIR CORPORATION
    Product Code
    IRT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2016 - WE HAVE REQUESTED THE DEVICE BE RETURNED TO THE MANUFACTURER. TO DATE, WE HAVE NOT RECEIVED THE DEVICE. ON (B)(6) 2017 - ADDED THE UPC CODE TO THE SUPPLEMENTAL EMDR. DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    ON 12/19/2016 - WE HAVE REQUESTED THE DEVICE BE RETURNED TO THE MANUFACTURER. TO DATE, WE HAVE NOT RECEIVED THE DEVICE. DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    ON 12/13/2016 - WE HAVE REQUESTED THE DEVICE BE RETURNED TO THE MANUFACTURER. TO DATE, WE HAVE NOT RECEIVED THE DEVICE. ON 1/30/2017 - ADDED THE UPC CODE TO THE SUPPLEMENTAL EMDR. ON 3/1/2017 - THE MFR. REPORT # WAS MISTAKENLY SUBMITTED AS A DUPLICATE. MFR. REPORT NUMBER SHOULD BE - 1222304-2016-00044. RESUBMITTING REPORT TO THE FDA. DEVICE NOT RETURNED TO MANFACTURER.

    Description of Event or Problem · 1

    ON (B)(6) 2016 - THE CONSUMER CLAIMS TO HAVE RECEIVED MARKS ON HER BACK WHEN IN USE OF THE PRODUCT. THE CONSUMER STATES THAT SHE WRAPS THE PRODUCT IN A TOWEL WHILE IN USE.

    Description of Event or Problem · 1

    ON (B)(6) 2016 - THE CONSUMER CLAIMS TO HAVE RECEIVED MARKS ON HER BACK WHEN IN USE OF THE PRODUCT. THE CONSUMER STATES THAT SHE WRAPS THE PRODUCT IN A TOWEL WHILE IN USE.

    Description of Event or Problem · 1

    ON (B)(6) 2016 - THE CONSUMER CLAIMS TO HAVE FALLEN ASLEEP WHILE IN USE OF THE PRODUCT. CONSUMER RECEIVED 2ND DEGREE BURN ON HIS BUTTOCKS. THE CONSUMER RECEIVED MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843769 CONAIR HEATING PAD IRT CONAIR CORPORATION HP01RB

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other