BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVERLET

    MDR report key: 26292 · Received September 29, 1995

    Report

    Report Number
    MW1007150
    Event Type
    Malfunction
    Date Received
    September 29, 1995
    Date of Event
    September 18, 1995
    Report Date
    September 25, 1995
    Manufacturer
    BEIERSDORF, INC.
    Product Code
    KGX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE ITEM WAS NOT APPLIED ON PT. HOWEVER, WHEN THE NURSE OPENED THE STERILE PACKAGE, THE WHITE PART OF THE DRESSING WAS BLACK INSTEAD OF WHITE AND THIS HAPPENED TWICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COVERLET ADHESIVE DRESSING KGX BEIERSDORF, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 *