BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KC200 ISOLATION GOWN

    MDR report key: 2554667 · Received April 23, 2012

    Report

    Report Number
    2554667
    Event Type
    Malfunction
    Date Received
    April 23, 2012
    Date of Event
    March 28, 2012
    Report Date
    April 23, 2012
    Manufacturer
    KIMBERLY-CLARK
    Product Code
    OEA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SD, US

    Narratives

    Description of Event or Problem · 1

    THE NEW ISOLATION GOWNS HAVE HOLES IN SLEEVE WHERE IT ATTACHES TO SHOULDER AND HAVE NO ELASTIC AT THE CUFF. WE HAD SWITCHED TO THIS PARTICULAR GOWN AND HAD PROBLEMS AT THAT TIME. NO GOWNS WERE GIVEN TO THIS REPORTER AND NO LOT NUMBERS WERE PROVIDED BUT THE MANUFACTURER FIELD REPRESENTATIVE WAS AWARE. PROBLEM SEEMED TO RESOLVE UNTIL EARLY THIS YEAR WHEN INFECTION CONTROL COLLECTED ABOUT 30 OF THE BRAND NEW GOWNS WITH THIS PROBLEM. STAFF WOULD OPEN THE NEW PACKAGE, TAKE OUT THE DISPOSABLE GOWN, TRY TO PUT IT ON AND DISCOVER THE HOLE OR THE MISSING ELASTIC. ALL HAD SAME LOT NUMBERS. STAFF DID NOT USE THE DEFECTIVE GOWN WHEN ENTERING THE ISOLATION ROOM, SO NO EXPOSURES OCCURRED BECAUSE OF THIS.======================MANUFACTURER RESPONSE FOR ISOLATION GOWNS, KC200 ISOLATION GOWN (PER SITE REPORTER)======================THE FIELD REPRESENTATIVE PICKED UP SEVERAL OF THE AFFECTED GOWNS AND SUGGESTED WE USE A DIFFERENT GOWN THAT WE HAVE ON STOCK. HOWEVER, THAT GOWN DOES NOT WORK FOR EVERYONE AS IT IS WAY TOO BIG. THIS GOWN (THE YELLOW ONE) IS USED BY THE MAJORITY OF OUR STAFF. THE FIELD REPRESENTATIVE HAD MENTIONED THAT ANOTHER HOSPITAL WAS ALSO HAVING THIS PROBLEM. A LETTER WAS RECEIVED FROM GLOBAL POST MARKET SURVEILLANCE THANKING US FOR OUR FEEDBACK AND APOLOGIZING FOR OUR INCONVENIENCE. NOTHING WAS SAID ABOUT A SOLUTION OR RESOLUTION TO THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KC200 ISOLATION GOWN ISOLATION GOWNS OEA KIMBERLY-CLARK KC 200 69979-97

    Patients

    Seq Age Sex Outcome Treatment
    1 *