BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONAIR

    MDR report key: 6368696 · Received March 1, 2017

    Report

    Report Number
    1222304-2016-00046
    Event Type
    Injury
    Date Received
    March 1, 2017
    Date of Event
    December 14, 2016
    Report Date
    April 28, 2021
    Manufacturer
    CONAIR CORPORATION
    Product Code
    IRT
    UDI-DI
    74108104670
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    12/19/2016 - WE HAVE REQUESTED THE DEVICE BE RETURNED TO THE MANUFACTURER. TO DATE, WE HAVE NOT RECEIVED THE DEVICE. 1/30/2017 - ADDED THE UPC CODE TO THE SUPPLEMENTAL EMDR. 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 MR. (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: 1222304-2016-00046 - 2, INITIAL, F/U-1.

    Additional Manufacturer Narrative · 0

    (B)(6) 2016 - WE HAVE REQUESTED THE DEVICE BE RETURNED TO THE MANUFACTURER. TO DATE, WE HAVE NOT RECEIVED THE DEVICE. 1/30/2017 - ADDED THE UPC CODE TO THE SUPPLEMENTAL EMDR (B)(6) 2017 - THE MFR. REPORT # WAS MISTAKENLY SUBMITTED AS A DUPLICATE. MFR. REPORT NUMBER SHOULD BE - 1222304-2016-00046. RESUBMITTING REPORT TO THE FDA. (B)(6) 2021 - PER THE FDA'S REQUEST, SUBMITTED A SUPPLEMENTAL MDR THAT DOES NOT INCLUDE THE AGE AND DOB.

    Description of Event or Problem · 0

    12/19/2016- THE CONSUMER CLAIMS TO HAVE RECEIVED MARKS ON HER BACK WHEN IN USE OF THE PRODUCT. THE CONSUMER STATES THAT SHE WARPS THE PRODUCT IN A TOWEL WHILE IN USE.

    Description of Event or Problem · 0

    (B)(6) 2016 - THE CONSUMER CLAIMS TO HAVE RECEIVED MARKS ON HER BACK WHEN IN USE OF THE PRODUCT. THE CONSUMER STATES THAT SHE WRAPS THE PRODUCT IN A TOWEL WHILE IN USE. (B)(6) 2021 - PER THE FDA'S REQUEST, SUBMITTED A SUPPLEMENTAL MDR THAT DOES NOT INCLUDE THE AGE AND DOB.

    Additional Manufacturer Narrative · 1

    (B)(6) 2016 - WE HAVE REQUESTED THE DEVICE BE RETURNED TO THE MANUFACTURER. TO DATE, WE HAVE NOT RECEIVED THE DEVICE. 1/30/2017 - ADDED THE UPC CODE TO THE SUPPLEMENTAL EMDR. 3/1/2017 - THE MFR REPORT # WAS MISTAKENLY SUBMITTED AS A DUPLICATE. MFR REPORT NUMBER SHOULD BE - 1222304-2016-00046. RESUBMITTING REPORT TO THE FDA. DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2016, WE HAVE REQUESTED THE DEVICE BE RETURNED TO THE MANUFACTURER. TO DATE, WE HAVE NOT RECEIVED THE DEVICE. ON 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. 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 , AND ADVISE WHEN COMPLETE. SUPPLEMENT REPORT # : TYPE OF REPORT MISSING: 1222304-2016-00046 - 2 ; INITIAL, F/U-1.

    Description of Event or Problem · 1

    (B)(6) 2016 - THE CONSUMER CLAIMS TO HAVE RECEIVED MARKS ON HER BACK WHEN IN USE OF THE PRODUCT. THE CONSUMER STATES THAT SHE WRAPS THE PRODUCT IN A TOWEL WHILE IN USE.

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE CONSUMER CLAIMS TO HAVE RECEIVED MARKS ON HER BACK WHEN IN USE OF THE PRODUCT. THE CONSUMER STATES THAT SHE WARPS THE PRODUCT IN A TOWEL WHILE IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153490 CONAIR HEATING PAD IRT CONAIR CORPORATION HP01RB 74108104670

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other