BEUDAMED
    FDA Adverse Event Other Summary report: N

    NUPREP

    MDR report key: 520571 · Received January 6, 2004

    Report

    Report Number
    1718791-2004-00001
    Event Type
    Other
    Date Received
    January 6, 2004
    Date of Event
    November 26, 2002
    Report Date
    January 6, 2004
    Manufacturer
    D.O. WEAVER AND C.
    Product Code
    GYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RECEIVED LETTER IN 12/2003 FROM PT. WROTE THAT PT EXPERIENCED BURNING AND BLISTERING WHEN UNDERGOING A HOLTER MONITOR (24 HOUR) EXAM. THEY APPLIED "CORTICOSE" CREAM TO THE AREA "BASED ON MY BACKGROUND AS A REGISTERED NURSE". PT TALKED TO "RISK MANAGEMENT DIRECTOR." RMD TOLD PT THAT THE REACTION WAS PROBABLY DUE TO THE GEL USED (NUPREP). PT SAID IN THE LETTER THAT PT IS LEFT WITH PERMANENT DAMAGE TO THE SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUPREP ABRASIVE SKIN PREP GEL GYB D.O. WEAVER AND C. 10-30 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other