BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISOLATION GOWN

    MDR report key: 2992088 · Received March 5, 2013

    Report

    Report Number
    2992088
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 20, 2013
    Report Date
    March 5, 2013
    Manufacturer
    KIMBERLY-CLARK
    Product Code
    FYC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SD, US

    Narratives

    Description of Event or Problem · 1

    NURSE WENT TO PUT ON ISOLATION GOWN PRIOR TO ENTERING ISOLATION ROOM. PUT LEFT ARM THROUGH SLEEVE AND DISCOVERED THAT THE ELASTIC WAS NOT ATTACHED TO MAKE THE CUFF TIGHT AROUND THE WRIST. THE RIGHT SLEEVE UPON INVESTIGATION WAS FOUND SEALED AT THE HAND. GOWN NOT USED. IT WAS TURNED IN TO INFECTION CONTROL WHO THEN SENT IT TO SAFETY DEPARTMENT. NO OTHER GOWNS FOUND UNUSABLE AT THIS TIME.======================MANUFACTURER RESPONSE FOR ISOLATION GOWN, KIMBERLEY-CLARK ISOLATION GOWN (PER SITE REPORTER).======================TALKED TO COMPANY REP VIA PHONE ON MARCH 1. HE SAID HE WOULD HAVE A MAILING LABEL SENT FOR THE GOWN TO BE RETURNED TO THEM FOR REVIEW. STILL WAITING FOR THIS LABEL.ALSO, THIS IS AN ISSUE THAT WE REPORTED IN 2012 TWICE AND STILL HAVE NOT RECEIVED AN OFFICIAL LETTER FROM THE COMPANY EXPLAINING WHY THE GOWNS ARE FAILING SO OFTEN.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?PROTECT STAFF FROM POTENTIAL EXPOSURE: TRANSMISSION BASED PRECAUTIONS, PATIENT IN ISOLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93940 ISOLATION GOWN GOWN, ISLOATION, SURGICAL FYC KIMBERLY-CLARK 69979-87 LG2 253

    Patients

    Seq Age Sex Outcome Treatment
    1 *