BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM PAK

    MDR report key: 178955 · Received July 24, 1998

    Report

    Report Number
    1644019-1998-00004
    Event Type
    Malfunction
    Date Received
    July 24, 1998
    Date of Event
    April 15, 1998
    Report Date
    June 23, 1998
    Manufacturer
    ALCON LABORATORIES, INC.
    Product Code
    KXX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER FACILITY REPORTS SKIN DRAPE WAS TOO STICKY AND PULLED OFF SOME OF THE PT'S SKIN. NEOSPORIN WAS APPLIED AND THE ABRASION RESOLVED. NO SERIOUS INJURY WAS REPORTED HOWEVER, THE REPORTER STATES THAT IF THIS EVENT WERE TO RECUR IT COULD RESULT IN A SERIOUS INNURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM PAK SURGICAL PAK KXX ALCON LABORATORIES, INC. NA WB66635

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN