BEUDAMED
    FDA Adverse Event Injury Summary report: N

    16-2210-0ISLAND DRESSING 50/BOX

    MDR report key: 24321857 · Received February 12, 2026

    Report

    Report Number
    3003348807-2026-00004
    Event Type
    Injury
    Date Received
    February 12, 2026
    Date of Event
    October 1, 2025
    Report Date
    February 12, 2026
    Manufacturer
    ZHENDE MEDICAL CO., LTD.
    Product Code
    NAC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON JAN. 26, 2026, WE FOUND THE REPORT BY SEARCHING THE MAUDE DATABASE. ZHENDE CONTACTED THE CUSTOMER TO ASK FOR MORE INFORMATION ABOUT THIS ADVERSE EVENT AND HAS NOT RECEIVED ANY REPLY. NO BATCH INFORMATION WAS PROVIDED, NEITHER THE AFFECTED DEVICE WAS PROVIDED. THE INFORMATION OF THE PATIENT IS NOT KNOWN AND THE USE SCENARIO WAS NOT PROVIDED, HENCE NO TESTING HAS BEGUN. WE WILL PROVIDE FOLLOWING REPORT WHEN WE HAVE MORE INFORMATION AND COMPLETE THE INVESTIGATION.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382727 16-2210-0ISLAND DRESSING 50/BOX Dressing, wound, hydrophilic NAC ZHENDE MEDICAL CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown