BEUDAMED
    FDA Adverse Event Other Summary report: N

    BARRIER EXTRA PROTECTION PLUS SURGICAL GOWN, EXTRA LARGE

    MDR report key: 461765 · Received May 21, 2003

    Report

    Report Number
    2523357-2003-00004
    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 INPERVIOUS GOWN. THE CUSTOMER ALLEGED STRIKETHROUGH OF FLUID IN THE ABDOMEN. A TOTAL OF FIVE INCIDENTS WERE REPORTED FROM 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. 3 ABOVE; SUBSEQUENT FOLLOW-UP BY TERRITORY SALES MANAGER WITH THE DOCTOR INVOLVED IN THE REPORTED INCIDENT FOUND THAT THE STRIKETHROUGH MAY HAVE OCCURRED IN THE THIGH/KNEE AREA, WHICH IS OUTSIDE OF THE REINFORCEMENT PANEL OF THE GOWN. NO BLOODBORRNE PATHOGEN EXPOSURE WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other