BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISLAND DRESSING

    MDR report key: 20228390 · Received September 13, 2024

    Report

    Report Number
    MW5159635
    Event Type
    Injury
    Date Received
    September 13, 2024
    Report Date
    September 11, 2024
    Manufacturer
    UNKNOWN
    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 THE ISLAND DRESSING ITCHES AND IRRITATES HER SKIN, ACCORDING TO THE PATIENT THE OLD BRAND OF ISLAND DRESSING DID NOT BOTHER HER. THE PATIENT ORDERED ANOTHER BOX AS SHE NEEDS THEM FOR HER SITE. PRODUCT #: 16-2210-0. 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
    1318403 ISLAND DRESSING DRESSING, WOUND, DRUG FRO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown