BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONAIR

    MDR report key: 15969560 · Received December 13, 2022

    Report

    Report Number
    1222304-2022-00041
    Event Type
    Malfunction
    Date Received
    December 13, 2022
    Date of Event
    November 22, 2022
    Report Date
    December 13, 2022
    Manufacturer
    CONAIR LLC.
    Product Code
    EFS
    UDI-DI
    85450000730
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    12/13/2022: THE CONSUMER ACCEPTED A REPLACEMENT PRODUCT AND WILL NOT RETURN THE DEVICE. THEREFORE AN INVESTIGATION WILL NOT OCCUR.

    Additional Manufacturer Narrative · 0

    12/13/2022 - THE CONSUMER ACCEPTED A REPLACEMENT PRODUCT AND WILL NOT RETURN THE DEVICE. THEREFORE AN INVESTIGATION WILL NOT OCCUR. 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 CORD SPARKED ON THE DEVICE AND BURNED PART OF THE DEVICE WHERE IT ATTACHES. INJURIES DID NOT OCCUR AND THE CONSUMER ACCEPTED A REPLACEMENT. THEREFORE AN INVESTIGATION WILL NOT OCCUR.

    Description of Event or Problem · 0

    12/13/2022 - THE CONSUMER CLAIMS THE CORD SPARKED ON THE DEVICE AND BURNED PART OF THE DEVICE WHERE IT ATTACHES. INJURIES DID NOT OCCUR AND THE CONSUMER ACCEPTED A REPLACEMENT. THEREFORE AN INVESTIGATION WILL NOT OCCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423712 CONAIR ORAL IRRIGATOR EFS CONAIR LLC. SWJ2 85450000730

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown