BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KC 100 LAVENDER NITRILE EXAM GLOVES

    MDR report key: 1364907 · Received March 20, 2009

    Report

    Report Number
    9614175-2009-00002
    Event Type
    Malfunction
    Date Received
    March 20, 2009
    Date of Event
    February 23, 2009
    Report Date
    March 19, 2009
    Manufacturer
    SAFESKIN MEDICAL AND 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 WILL NOT BE 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

    KIMBERLY CLARK HAS RECEIVED A COMPLAINT INDICATED THAT "DURING THE CLEANING OF THE PATIENT'S ROOM, THE EMPLOYEE'S GLOVE TORE EXPOSING THEM TO THE PATIENT'S BODY FLUIDS". THERE WAS NO REPORT ANY 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. (B) (4).

    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 AND SCIENTIFIC SM82563PX

    Patients

    Seq Age Sex Outcome Treatment
    1