BEUDAMED
    FDA Adverse Event Summary report: N

    EXAM GLOVES NITRILE

    MDR report key: 3150582 · Received June 6, 2013

    Report

    Report Number
    9680760-2013-00002
    Date Received
    June 6, 2013
    Report Date
    May 6, 2013
    Manufacturer
    KIMBERLY-CLARK HEALTH CARE
    Product Code
    FMC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED AND DOCUMENTED THAT THE PRODUCT LOT REPORTED IN THE INCIDENT MET MANUFACTURING SPECIFICATIONS. THE DEVICE WAS NOT RETURNED TO KIMBERLY-CLARK FOR EVALUATION, THEREFORE WE ARE UNABLE TO DETERMINE A ROOT CAUSE FOR THE REPORTED EVENT. 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, ¿THE FIRST TIME A JUNIOR RESCUE VOLUNTEER WORKER WORE THE PURPLE NITRILE GLOVES, HER HANDS BECAME 'ITCHY.' THE SECOND TIME SHE WORE THE GLOVES, A WEEK OR SO LATER, HER WHOLE BODY BECAME 'ITCHY.' THE THIRD TIME SHE WORE THE GLOVES, SHE HAD DIFFICULTY BREATHING AND SWALLOWING WHILE ASSISTING A PATIENT IN THE AMBULANCE. EMT PERSONNEL CALLED HER MOTHER AND 20 MINUTES LATER ADMINISTERED TWO BENADRYL CAPLETS WHICH ALLEVIATED HER SYMPTOMS COMPLETELY. SHE HAS NOT HAD ANY ISSUES SINCE THE THIRD INCIDENT.¿ 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. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251700 EXAM GLOVES NITRILE GLOVES FMC KIMBERLY-CLARK HEALTH CARE SC2346ZZZ_06BX

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR