BEUDAMED
    FDA Adverse Event Summary report: N

    MEDICAL ACTION INDUSTRIES

    MDR report key: 6176077 · Received December 15, 2016

    Report

    Report Number
    1030451-2016-00017
    Date Received
    December 15, 2016
    Date of Event
    November 14, 2016
    Report Date
    December 12, 2016
    Manufacturer
    MEDICAL ACTION INDUSTRIES
    Product Code
    NAB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REGISTERED NURSE STATED THAT THIS PATIENT IS HIGHLY ALLERGIC TO 4X4 ISLAND DRESSING PRODUCT, 44258. DIALYSIS NURSE REPORTED THAT "SUPPLIES" HAVE BEEN IRRITATING THE PATIENT'S SKIN AND HAS CAUSED THE PATIENT TO HAVE BLISTERS. THE PATIENT DID NOT GO TO THE DOCTOR FOR TREATMENT OF THE BLISTERS. FRESENIUS USED AN ASEPTIC CLEANER, AIR DRIED THE BLISTERS, AND THEN PLACED 2X2 GAUZE SOAKED IN SALINE ON THE BLISTERS FOR TREATMENT. FRESENIUS MENTIONED THAT THIS PATIENT IS HIGHLY ALLERGIC TO VARIOUS DRESSINGS AND SUPPLIES SUCH AS TEGADERMS, TAPES, ETC.; NOT JUST THIS DRESSING. FRESENIUS HAS FOUND ANOTHER PRODUCT TO REPLACE THIS DRESSING FOR USE ON THE INVOLVED PATIENT. THE ISLAND DRESSING PRODUCT IS IMPORTED BY (B)(4); HOWEVER, THE DRESSING IS MANUFACTURED BY SHANGHAI WELLONG MEDICAL MATERIALS CO., LTD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829816 MEDICAL ACTION INDUSTRIES GAUZE: ISLAND DRESSING 4X4 600/CS NAB MEDICAL ACTION INDUSTRIES 44258 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other