BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD BELT, MEDIUM 30"-44", 3 PER PK

    MDR report key: 20864156 · Received December 5, 2024

    Report

    Report Number
    MW5163283
    Event Type
    Malfunction
    Date Received
    December 5, 2024
    Report Date
    December 4, 2024
    Manufacturer
    UNKNOWN
    Product Code
    FJS
    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 FRESENIUS MEDICAL CARE NORTH AMERICA. A PERITONEAL DIALYSIS (PD) PATIENT CONTACTED FRESENIUS CUSTOMER SERVICE TO REPORT AN ISSUE AGAINST THE PD BELT, MEDIUM 30"-44", 3 PER PK. THE PATIENT REPORTED THE PD BELT MATERIAL WAS HARD AND ROUGH ON HIS SKIN. THE PATIENT INVOLVEMENT WAS 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). REFER TO ADDITIONAL DOCUMENTS IN I2K.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94292 PD BELT, MEDIUM 30"-44", 3 PER PK CATHETER, PERITONEAL, LONG-TERM INDWELLING FJS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown