BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    12" X 24" HEATING PAD, THREE SETTING

    MDR report key: 21071880 · Received January 2, 2025

    Report

    Report Number
    MW5164274
    Event Type
    Malfunction
    Date Received
    January 2, 2025
    Date of Event
    December 25, 2024
    Report Date
    December 31, 2024
    Manufacturer
    BV MEDICAL / BARRINGTON VENTURES, LTD.
    Product Code
    IRT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PLEASE NOTE THE ATTACHED COMPLAINT INVOLVES A DEVICE ASSOCIATED WITH AN ADVERSE EVENT THAT IS NOT MANUFACTURED BY (B)(6). A PERITONEAL DIALYSIS (PD) PATIENT CONTACTED (B)(6) CUSTOMER SERVICE TO ADVISE THAT THEIR HEATING PAD MELTED. THEY WENT TO TAKE IT OUT OF THE BOX THEY KEPT IT IN AND IT WOULD NOT LAY FLAT. WHEN OPENING IT UP TO CHECK, THEY FOUND PARTS MELTED. IT WAS AFTER PREVIOUS USE AND DID NOT CAUSE ANY PROBLEMS FOR PATIENT OR PT'S SOLUTION, THE PATIENT INVOLVEMENT IS UNKNOWN HOWEVER THERE WAS NO HARM OR ADVERSE EVENT REPORTED. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    949475 12" X 24" HEATING PAD, THREE SETTING PAD, HEATING, POWERED IRT BV MEDICAL / BARRINGTON VENTURES, LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown