BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONAIR

    MDR report key: 9125283 · Received September 26, 2019

    Report

    Report Number
    1222304-2019-00023
    Event Type
    Malfunction
    Date Received
    September 26, 2019
    Date of Event
    August 23, 2019
    Report Date
    August 26, 2019
    Manufacturer
    CONAIR CORPORATION
    Product Code
    IRT
    UDI-DI
    74108355560
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    9/192019 - THE CONSUMER ACCEPTED A REPLACEMENT PRODUCT. THEREFORE AN INVESTIGATION WILL NOT TAKE PLACE.

    Description of Event or Problem · 1

    8/26/2019 - THE CONSUMER CLAIMS THE PRODUCT SPARKED WHILE IN USE OF THE PRODUCT. THE CONSUMER WILL BE SENDING THE PRODUCT TO OUR FACILITIES FOR REVIEW. THE CONSUMER REQUESTED A REPLACEMENT PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920638 CONAIR HEATING PAD IRT CONAIR CORPORATION HP01XF 74108355560

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other