BEUDAMED
    FDA Adverse Event Other Summary report: N

    BARRIER EXTRA PROTECTION PLUS GOWN, LARGE

    MDR report key: 461764 · Received May 21, 2003

    Report

    Report Number
    2523357-2003-00003
    Event Type
    Other
    Date Received
    May 21, 2003
    Date of Event
    April 20, 2003
    Report Date
    May 20, 2003
    Manufacturer
    MOLNLYCKE HEALTH CARE, INC.
    Product Code
    FYE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INITIAL REPORT FROM TERRITORY SALES MANAGER, CONCERNING AN ACCOUNT THAT HAD JUST CONVERTED FROM USING AN ENTIRE FLUID IMPERVIOUS GOWN TO A FLUID ZONED IMPERVIOUS GOWN. THE CUSTOMER ALLEGED STRIKETHROUGH OF FLUID IN THE ABDOMEN. A TOTAL OF FIVE INCIDENTS WERE REPORTED BY THIS HOSPITAL FOR THE FOLLOWING: 1) BOWEL RESECTION, 2) INCISION AND DRAINAGE (I&D) - TWO SURGEONS, 3) TOTAL HIP REPLACEMENT AND 4) SEVERE GUNSHOT WOUND. THIS REPORT IS FILED FOR NO. 2 ABOVE (SECOND ALLEGED INCIDENT IN I&D SURGERY): TERRITORY SALES MANAGER VISITED THE HOSPITAL AND WAS UNABLE TO GATHER ADDITIONAL INFO FOR THIS REPORT. NO BLOODBORNE PATHOGEN EXPOSURE WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other