BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONAIR

    MDR report key: 15969620 · Received December 13, 2022

    Report

    Report Number
    1222304-2022-00042
    Event Type
    Malfunction
    Date Received
    December 13, 2022
    Date of Event
    November 29, 2022
    Report Date
    December 13, 2022
    Manufacturer
    CONAIR LLC.
    Product Code
    IRT
    UDI-DI
    74108448316
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    12/13/2022 - WE HAVE REQUESTED THE DEVICE BE RETURNED TO THE MANUFACTURER FOR AN INVESTIGATION. TO DATE, WE HAVE NOT RECIEVED THE DEVICE.

    Additional Manufacturer Narrative · 0

    ON 12/13/2022 - WE HAVE REQUESTED THE DEVICE BE RETURNED TO THE MANUFACTURER FOR AN INVESTIGATION. TO DATE, WE HAVE NOT RECIEVED THE DEVICE. ON 7/8/2023 - SUBMITTING A SUPPLEMENTAL EMDR TO THE FDA AS WE MISTAKENLY ENTERING THE INCORRECT MEDICAL DEVICE PROBLEM CODE. CHANGING THE MEDICAL DEVICE PROBLEM CODE "FAIL-SAFE PROBLEM TO "APPROPRIATE TERM / CODE NOT AVAILABLE.

    Description of Event or Problem · 0

    12/13/2022 - THE CONSUMER CLAIMS THE PRODUCT BURNED AND CAUSED DAMAGE TO HER BEDDING AND MATTRESS. INJURIES DID NOT OCCUR.

    Description of Event or Problem · 0

    ON (B)(6) 2022 - THE CONSUMER CLAIMS THE PRODUCT BURNED AND CAUSED DAMAGE TO HER BEDDING AND MATRRESS. INJURIES DID NOT OCCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2297935 CONAIR HP08FW IRT CONAIR LLC. HP08FW 74108448316

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown