BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONAIR

    MDR report key: 22113076 · Received May 30, 2025

    Report

    Report Number
    1222304-2025-00002
    Event Type
    Malfunction
    Date Received
    May 30, 2025
    Date of Event
    December 23, 2024
    Report Date
    March 6, 2025
    Manufacturer
    CONAIR LLC.
    Product Code
    IRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    1/23/2025 - WE HAVE REQUESTED THE DEVICE BE RETURNED FROM THE CONSUMER. TO DATE, WE HAVE NOT RECEIVED THE DEVICE. 3/6/2025 - IT WAS DISCOVERED AN ERROR IN THE FDA MANUFACTURER NUMBER WAS INCORRECT. RESUBMITTING AN SUPPLEMENTAL EMDR WITH THE CORRRECT FDA MANUFACTURER NUMBER. THE ORIGINAL MANUFACTURER REPORT NUMBER WAS 1222301-2020-00002. THE CORRECT MANUFACTURER NUMBER SHOULD BE 1222304-2025-00002. THE INITIAL MDR WAS SUBMITTED VIA THE OLDER ESG SYSTEM AND WILL BE RESUBMITTING VIA THE NEW ESG SYSTEM AS AN INITIAL REPORT.

    Description of Event or Problem · 0

    1/23/2025 - THE CONSUMER CLAIMS THE PRODUCT HAD A BURNT SMELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13324 CONAIR HEATING PAD IRT CONAIR LLC. HP34

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other