BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILVER ALGINATE II DRESSING

    MDR report key: 7730581 · Received July 30, 2018

    Report

    Report Number
    8044178-2018-00001
    Event Type
    Malfunction
    Date Received
    July 30, 2018
    Report Date
    July 30, 2018
    Manufacturer
    ADVANCED MEDICAL SOLUTIONS LTD
    Product Code
    FRO
    PMA / PMN Number
    K070581
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED UPON THE AVAILABLE INFORMATION THE INCIDENT IS DEEMED A REPORTABLE MALFUNCTION. THE DRESSING WAS NOT USED. THE PRIMARY AND SECONDARY PACKAGING INCLUDES THE STATEMENT "STERILE IN UNOPENED, UNDAMAGED PACKAGE".

    Description of Event or Problem · 1

    PRIMARY PACKAGING OF WOUND DRESSING "WAS PRINTED, CUT, AND SEALED INCORRECTLY".PHOTOS DEPICTING THE REPORTED COMPLAINT WERE PROVIDED BY THE COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575661 SILVER ALGINATE II DRESSING ANTIMICROBIAL WOUND DRESSING FRO ADVANCED MEDICAL SOLUTIONS LTD 26373

    Patients

    Seq Age Sex Outcome Treatment
    1