BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KC 100 LAVENDER NITRILE EXAM GLOVES

    MDR report key: 1341795 · Received March 9, 2009

    Report

    Report Number
    9614175-2009-00001
    Event Type
    Malfunction
    Date Received
    March 9, 2009
    Date of Event
    January 27, 2009
    Report Date
    March 9, 2009
    Manufacturer
    SAFESKIN MEDICAL & SCIENTIFIC
    Product Code
    LZA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT SAMPLE HAS NOT YET BEEN RECEIVED FOR EVALUATION. INVESTIGATION IS IN-PROCESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED WHEN ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT & MDR TREND REPORTING SYSTEMS. ONGOING ANALYSIS OF TREND INFORMATION IS USED TO IDENTIFY THE NEED FOR ADDITIONAL INVESTIGATIONS.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED BY A KIMBERLY CLARK SALES REPRESENTATIVE THAT WHILE A NURSE WAS PUTTING PRESSURE ON A MAJOR ARTERY IN A CARDIAC'S PATIENT'S LEG, THE GLOVE BROKE. IT WAS REPORTED THAT THE CLINICIAN GOT A "GREAT DEAL OF BLOOD" GOT ON HER HANDS. THERE WAS NO REPORT OF COMMUNICABLE DISEASES OR ANY HARM TO THE USER. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KC 100 LAVENDER NITRILE EXAM GLOVES MEDICAL EXAM GLOVES, NITRILE LZA SAFESKIN MEDICAL & SCIENTIFIC SM82413PV

    Patients

    Seq Age Sex Outcome Treatment
    1