BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONAIR

    MDR report key: 5470249 · Received March 1, 2016

    Report

    Report Number
    1222304-2016-00007
    Event Type
    Injury
    Date Received
    March 1, 2016
    Date of Event
    January 3, 2016
    Report Date
    January 20, 2016
    Manufacturer
    CONAIR CORPORATION
    Product Code
    IRT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    01/26/2016 - WE HAVE REQUESTED THE PRODUCT BE RETURND FOR EVALUATION. THE PRODUCT HAS NOT BEEN RECEIVED TO DATE. 10/23/2020 - PER FDA REPRESENTATIVE (B)(6), WE HAVE BEEN REQUESTED TO RESUBMIT OUR INITIAL REPORTS DUE ERROR'S OR DUPLICATE REPORTS FROM THE 2016 - 2017. THE REPORTS WE BE RESUBMITTED TO SATISFY THE FDA'S REQUEST. GOOD MORNING, DEAR (B)(6). I HOPE THIS EMAIL FINDS YOU WELL AND SAFE. THIS IS TO BRING TO YOUR ATTENTION THAT WE ARE IN RECEIPT OF SEVEN SUPPLEMENT REPORTS FROM CONAIR CORP. PLEASE NOTE THAT WE WERE UNABLE TO PROCESS THESE FOLLOW-UP REPORTS DUE TO MISSING INITIAL REPORTS IN THE SYSTEM. IT APPEARS THAT THESE FOLLOW-UP REPORTS COULD BE ACTUAL INITIAL REPORTS BUT MAY HAVE BEEN FILED AS FOLLOW-UPS IN ERROR OR DUE TO MFR REPORT # WAS MISTAKENLY SUBMITTED AS A DUPLICATE (NO # PROVIDED). KINDLY VERIFY THE REPORTS LISTED BELOW AND RESUBMIT THEM AS INITIALS BY CHECKING "INITIAL" BOX IN SECTION G7 AND ADVISE WHEN COMPLETE. SUPPLEMENT REPORT #: 1222304-2016-00007 - 1. TYPE OF REPORT MISSING: INITIAL.

    Description of Event or Problem · 1

    (B)(6) 2016: THE CONSUMER ALLEGES THAT THE PRODUCT HAS BURNED HER HAND WHILE IN USE. THE CONSUMER DID NOT RECEIVE MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129110 CONAIR HEATED MITT IRT CONAIR CORPORATION JBHM1NC

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Other