BEUDAMED
    FDA Adverse Event Other Summary report: N

    DRAPE TAPES

    MDR report key: 455699 · Received April 24, 2003

    Report

    Report Number
    1423507-2003-00057
    Event Type
    Other
    Date Received
    April 24, 2003
    Date of Event
    March 27, 2003
    Report Date
    April 24, 2003
    Manufacturer
    CARDINAL HEALTH
    Product Code
    KGT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT'S SKIN WAS PEELED OFF WHEN THE DRAPE TAPE WAS REMOVED. THE SAME SURFACE AREA AS THE TAPE SIZE, (10X15CM) WAS PEELED. IT TOOK ONE AND A HALF HOURS FOR THE OPERATION. THEY DIDN'T USE ANY CHEMICALS EXCEPT POVIDONE SOLUTION AND PHYSIOLOGICAL SALINE. THERE WERE DAMAGED AREAS TO THE PT'S STRATUM CORNEUM OR STRATUM LUCIDUM, NOT THE WHOLE EPIDERMIS. THE PT WAS GIVEN THE OINTMENT OF OXYTERACYCLINE HCL/HYDROCORTISONE. THE NEXT DAY, THE REDDISH PEELED AREA APPEARED NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRAPE TAPES DRAPE TAPES KGT CARDINAL HEALTH 3524CE 02HBJ028

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other