BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RITMED NON-WOVEN ISLAND DRESSING

    MDR report key: 21953078 · Received May 2, 2025

    Report

    Report Number
    9611959-2025-00004
    Event Type
    Injury
    Date Received
    May 2, 2025
    Date of Event
    February 25, 2025
    Report Date
    May 2, 2025
    Manufacturer
    AMD MEDICOM INC.
    Product Code
    KGX
    UDI-DI
    10686864051203
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT WAS INITIALLY REPORTED TO THE FDA VIA VOLUNTARY MEDWATCH MW5167810. THIS REPORT IS TO ACKNOWLEDGE RECEIPT OF THE MEDWATCH FORM, RECEIVED BY AMD MEDICOM ON APRIL 23, 2025. SINCE NO LOT NUMBER WAS PROVIDED, A THOROUGH INVESTIGATION CANNOT BE PERFORMED. THE MANUFACTURER CONFIRMED THAT THERE WAS NO CHANGE ON USED ADHESIVE, MANUFACTURING TECHNOLOGY WAS FOUND. THE ADHESIVE GRAMMAGE, PEELING STRENGTH WERE ALL CHECKED BEFORE THE RELEASE. THEREFORE, NO ROOT CAUSE COULD BE DETERMINED, AND THE MANUFACTURER STATES THAT THIS EVENT COULD BE RELATED WITH USE CONDITION, PASTING TIME, PASTING METHOD, PASTING POSITION AND PERSONNEL SKIN STATUS. THE BIOCOMPATIBILITY TEST WAS RECHECKED FOR THIS PRODUCT, AND THE RESULTS ARE PASS.

    Description of Event or Problem · 0

    PATIENT CONTACTED FRESENIUS CUSTOMER SERVICE TO REPORT THE TAPE FROM THE ISLAND DRESSING IRRITATES HER SKIN WHEN SHE USES IT. THE PATIENT INVOLVEMENT IS UNKNOWN HOWEVER THERE WAS NO HARM OR ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1072369 RITMED NON-WOVEN ISLAND DRESSING WOUND DRESSING KGX AMD MEDICOM INC. A50044 10686864051203

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown