BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEALTHTOUCH POWDER-FREE LATEX EXAM GLOVES

    MDR report key: 931721 · Received October 24, 2007

    Report

    Report Number
    9617444-2007-00140
    Event Type
    Malfunction
    Date Received
    October 24, 2007
    Date of Event
    September 26, 2007
    Report Date
    October 24, 2007
    Manufacturer
    BRIGHTWAY HOLDINGS SDN. BHD.
    Product Code
    LYY
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE OF THE DEVICE WILL NOT BE RETURNED FOR EVAL. INFO FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEMS. ONGOING ANALYSIS OF TREND INFO IS USED TO IDENTIFY THE NEED FOR ADD'L INVESTIGATIONS.

    Description of Event or Problem · 1

    DURING USE OF THE EXAM GLOVE, LAB PERSONNEL ARE EXPERIENCING GLOVE FINGERS SPLITTING OPEN. THE USER FACILITY CITED NO ADVERSE EVENT OR MEDICAL INTERVENTION. HOWEVER, THEY EXPRESSED CONCERN OF POTENTIAL EXPOSURE TO INFECTIOUS DISEASES AND VARIOUS REAGENTS THAT SHOULD NOT TOUCH THEIR SKIN. KIMBERLY - CLARK HAD NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFO THAT WAS PROVIDED BY THE USER FACILITY, WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE KIMBERLY - CLARK COMPLAINT DATABASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEALTHTOUCH POWDER-FREE LATEX EXAM GLOVES GLOVES LYY BRIGHTWAY HOLDINGS SDN. BHD. NA SB6260634

    Patients

    Seq Age Sex Outcome Treatment
    1 YR