BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISLAND DRESSING 50/BOX

    MDR report key: 22898039 · Received August 26, 2025

    Report

    Report Number
    MW5175258
    Event Type
    Injury
    Date Received
    August 26, 2025
    Date of Event
    July 31, 2025
    Report Date
    August 14, 2025
    Manufacturer
    ZHENDE MEDICAL CO., LTD.
    Product Code
    FRO
    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 (B)(6) CUSTOMER SERVICE TO REPORT A 16-2210-0 - ISLAND DRESSING 50/BOX. THE PATIENT HAS BEEN RECEIVING RIT MED BRAND OF ISLAND DRESSING AND IT IS IRRITATING PATIENT'S SKIN. PATIENT SAYS HIS SKIN IS PEELING OFF WHEN HE USES AND HE IS BLEEDING. THE PATIENT SAYS WE ALSO HAVE MEDICAL ACTION BRAND OF ISLAND DRESSING AND HE WANTS THAT BECAUSE IT WORKS FOR HIM. "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
    1380378 ISLAND DRESSING 50/BOX DRESSING, WOUND, DRUG FRO ZHENDE MEDICAL CO., LTD. 16-2210-0

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown