BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, THERMAL REGULATING

    MDR report key: 17729725 · Received September 12, 2023

    Report

    Report Number
    1219702-2023-00036
    Event Type
    Malfunction
    Date Received
    September 12, 2023
    Report Date
    September 15, 2023
    Product Code
    DWJ
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CITED WRAPS WERE DISPOSED OFF AND WILL NOT BE AVAILABLE FOR INVESTIGATION. REVIEW OF THE RETAIN SAMPLE FOR THE LOT WAS CONDUCTED AND NO ISSUES WERE FOUND. NO OTHER COMPLAINTS FOR THIS LOT HAVE BEEN NOTED FROM ANY OTHER LOCATION. BELMONT CONTACTED THE USER TO PROVIDE INFORMATION ON THE LOCATION OF WHERE THE LEAKS OCCURRED AND IF THEY HAVE ANY PHOTOGRAPHS OR VIDEO OF THE ALLEGED LEAKS BUT NO ADDITIONAL INFORMATION HAS BEEN PROVIDED ON THE LOCATION OF THE ALLEGED LEAKS FROM THE USER. THE WRAPS WERE CONFIRMED AS DISCARDED, THEREFORE NO INVESTIGATION COULD BE PERFORMED ON THE CITED WRAPS. NO OTHER LEAKS /COMPLAINTS HAVE BEEN REPORTED FROM EITHER LOT. WE RECEIVED ONE ALLEGED FAILURE FROM THIS USER FOR LOT M202661. THE LOT SIZE FOR M202661 WAS 1064 AND THE FAILURE RATE = (B)(4). NO OTHER USER HAS REPORTED AN ISSUE THIS LOT. WE RECEIVED THREE ALLEGED FAILURES FROM THIS USER FOR LOT #M220191. THE LOT SIZE FOR LOT #M220191 WAS 1248 AND THE FAILURE RATE = 0.24%.NO OTHER USER HAS REPORTED AND ISSUE WITH THIS LOT. NO PATIENT HARM WAS REPORTED. WITHOUT THE ABILITY TO REVIEW THE DEVICES WE ARE UNABLE TO CONFIRM THE ISSUE OR DETERMINE A ROOT CAUSE OF THE ALLEGED LEAK. BELMONT WILL CONTINUE TO MONITOR THIS ISSUE MOVING FORWARD.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED AS A CORRECTION TO THE MANUFACTURER REPORT NUMBER FOR THE MDR REPORT SUBMITTED ON JULY 27, 2023 WHICH HAD MANUFACTURER REPORT NUMBER:1219792-2023-00036 INSTEAD OF CORRECT NUMBER FOR BELMONT: 1219702.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676384 SYSTEM, THERMAL REGULATING DWJ

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown