BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONAIR

    MDR report key: 6530497 · Received April 28, 2017

    Report

    Report Number
    1222304-2017-00017
    Event Type
    Malfunction
    Date Received
    April 28, 2017
    Date of Event
    March 15, 2017
    Report Date
    April 17, 2017
    Manufacturer
    CONAIR CORPORATION
    Product Code
    IRT
    UDI-DI
    00074108291646
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2017, THE CONSUMER AGREED TO RECEIVE A REFUND CHECK. AN INVESTIGATION WILL NOT BE REQUIRED. ON (B)(6) 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. 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 #: TYPE OF REPORT MISSING: 1222304-2017-00017 - 1 INITIAL.

    Description of Event or Problem · 1

    ON (B)(6) 2017, THE CONSUMER CLAIMS THAT THE GLASS SHATTERED ON THE PRODUCT WHILE STEPPING ON IT. THE CONSUMER AGREE TO RECEIVE A REFUND CHECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313488 CONAIR HEATING PAD IRT CONAIR CORPORATION WW27 00074108291646

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female Other