BEUDAMED
    FDA Adverse Event Injury Summary report: N

    16-2210-0ISLAND DRESSING 50/BOX

    MDR report key: 23618477 · Received November 21, 2025

    Report

    Report Number
    MW5179250
    Event Type
    Injury
    Date Received
    November 21, 2025
    Date of Event
    October 1, 2025
    Report Date
    November 19, 2025
    Manufacturer
    ZHENDE MEDICAL CO., LTD.
    Product Code
    NAC
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    A PERITONEAL DIALYSIS (PD) PATIENT CONTACTED CUSTOMER SERVICE TO REPORT THAT SHE WAS ALLERGIC TO THE ISLAND DRESSING, DOES NOT KNOW WHEN SHE RECEIVED THEM AND CAN'T GET A LOT# OFF THE BOX. SHE SAID SHE JUST STOPPED ORDERING THEM. "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
    2490715 16-2210-0ISLAND DRESSING 50/BOX DRESSING, WOUND, HYDROPHILIC NAC ZHENDE MEDICAL CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown