BEUDAMED
    FDA Adverse Event Other Summary report: N

    BARRIER EXTRA PROTECTION PLUS SURGICAL GOWN

    MDR report key: 350021 · Received August 31, 2001

    Report

    Report Number
    2523357-2001-00001
    Event Type
    Other
    Date Received
    August 31, 2001
    Date of Event
    August 2, 2001
    Report Date
    August 28, 2001
    Manufacturer
    MOLNLYCKE HEALTH CARE, INC.
    Product Code
    FYE
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    REPORT RECEIVED THAT WHILE PERFORMING A LENGTHY AND BLOODY ABDOMINAL CASE, STRIKETHROUGH OCCURRED AROUND THE SLEEVE FROM ABOUT THE AREA JUST ABOVE THE CUFF OF THE GLOVE TO JUST BELOW THE ELBOW. THE SURGEON USES EUDERMIC GLOVES THAT DO NOT HAVE A BEADED CUFF, HOWEVER, THE SURGEON DOES NOT ATTRIBUTE THE STRIKETHROUGH BECAUSE OF THE GLOVES. NO KNOWN BLOOD BORNE PATHOGENS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39671 BARRIER EXTRA PROTECTION PLUS SURGICAL GOWN GOWN, SURGICAL FYE MOLNLYCKE HEALTH CARE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other