BEUDAMED
    FDA Adverse Event Injury Summary report: N

    31-HP800-0, 12" X 24" HEATING PAD, THREE SETTING

    MDR report key: 21840235 · Received April 15, 2025

    Report

    Report Number
    MW5169026
    Event Type
    Injury
    Date Received
    April 15, 2025
    Date of Event
    February 7, 2025
    Report Date
    April 10, 2025
    Manufacturer
    BARRINGTON VENTURES, LTD
    Product Code
    IRT
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    A PERITONEAL DIALYSIS (PD) PATIENT CONTACTED FRESENIUS CUSTOMER SERVICE TO REPORT THAT THE 31-HP800-0, HEATING PAD NO LONGER WORKS, IT IS NOT HEATING THE SOLUTION ENOUGH. THE PATIENT IS NOT SURE WHAT EXACTLY HAPPENED TO IT. THE PATIENT EXPERIENCED CRAMPING DUE TO USING THE SOLUTION COLD, BUT DID NOT HAVE TO GO TO THE HOSPITAL. 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
    114089 31-HP800-0, 12" X 24" HEATING PAD, THREE SETTING PAD, HEATING, POWERED IRT BARRINGTON VENTURES, LTD 10132023

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown