BEUDAMED
    FDA Adverse Event Injury Summary report: N

    16-2210-0 ISLAND DRESSING 50/BOX

    MDR report key: 22545909 · Received July 18, 2025

    Report

    Report Number
    MW5172958
    Event Type
    Injury
    Date Received
    July 18, 2025
    Date of Event
    July 14, 2025
    Report Date
    July 7, 2025
    Manufacturer
    ZHENDE MEDICAL CO., LTD.
    Product Code
    FRO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    A PERITONEAL DIALYSIS (PD) PATIENT CONTACTED (B)(6) CUSTOMER SERVICE TO REPORT A 16-2210-0 - ISLAND DRESSING 50/BOX. THE PATIENT STATED, THE ISLAND DRESSINGS IS CAUSING HIM ITCHINESS AND HAS A RASH FROM SCRATCHING. THERE WAS PATIENT INVOLVEMENT, ITCHINESS AND RASH 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
    2785614 16-2210-0 ISLAND DRESSING 50/BOX DRESSING, WOUND, DRUG FRO ZHENDE MEDICAL CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown