BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PD BELT

    MDR report key: 25159025 · Received May 12, 2026

    Report

    Report Number
    MW5188093
    Event Type
    Injury
    Date Received
    May 12, 2026
    Report Date
    May 5, 2026
    Manufacturer
    UNKNOWN
    Product Code
    OAG
    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 CUSTOMER SERVICE TO REPORT THE MATERIAL OF THE PD BELT. THE PATIENT ADVISES THAT THE PD BELT CAUSED REDNESS OF THE SKIN ON THE SIDE EVEN WHEN APPLIED WITH THE VELCRO NOT TOUCHING THE SKIN, ADVISED USING ANOTHER PRODUCT INSTEAD OF THE PD BELT. THERE WAS PATIENT REACTION 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
    464734 PD BELT GARMENT, STORAGE, PERITONEAL DIALYSIS CATHETER OAG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown