BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KC 100 LAVENDER TEXURED GLOVES

    MDR report key: 2503088 · Received March 26, 2012

    Report

    Report Number
    9680760-2012-00002
    Event Type
    Injury
    Date Received
    March 26, 2012
    Report Date
    February 24, 2012
    Manufacturer
    KIMBERLY-CLARK HEALTH CARE
    Product Code
    LZA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED AND PRODUCT MET ALL MANUFACTURING SPECIFICATIONS. THE RETURNED COMPANION GLOVE SAMPLES WERE TESTED AND MET ALL TESTING CRITERIA. AS PART OF THE PRE-MARKET CLEARANCE FOR THIS PRODUCT, THE NECESSARY DERMAL SENSITIZATION AND SKIN IRRITATION TESTING HAD BEEN PERFORMED WITH PASSING RESULTS. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEMS. ONGOING ANALYSIS OF TREND INFORMATION IS USED TO IDENTIFY THE NEED FOR ADDITIONAL INVESTIGATIONS.

    Description of Event or Problem · 1

    KIMBERLY-CLARK RECEIVED A REPORT STATING, "CARE COORDINATOR HAD A ANAPHYLACTIC REACTION WHILE WEARING LAVENDER GLOVES. USER'S SYMPTOMS WERE FLUSHING TO THE HANDS, CHEST, ITCHING, TACHYCARDIA AND LIGHTHEADEDNESS. SHE WAS GIVEN EPINEPHRINE 1/1000, 0.15 SUBQ TIMES 2. BENADRYL 50MG IV, ZYRTEC 10MG PO. TRANSPORTED TO THE HOSPITAL WHERE SHE RECEIVED IV FLUIDS, SOLUMEDROL 125MG IV AND WAS DISCHARGED WITH A PRESCRIPTION FOR PO PREDNISONE. SHE IS DOING WELL AND RETURNED TO WORK THE NEXT DAY. KIMBERLY-CLARK HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE KIMBERLY-CLARK COMPLAINT DATABASE AND IDENTIFIED AS RECORD (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KC 100 LAVENDER TEXURED GLOVES LAVENDER GLOVES LZA KIMBERLY-CLARK HEALTH CARE SP0123301

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR