BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UTILITY GLOVE 40-060

    MDR report key: 1898480 · Received November 8, 2010

    Report

    Report Number
    MW5018147
    Event Type
    Malfunction
    Date Received
    November 8, 2010
    Report Date
    November 8, 2010
    Manufacturer
    HU-FRIEDY MFG CO., INC.
    Product Code
    LYY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    OSHA AND THE CDC REQUIRE THE USE OF PUNCTURE-RESISTANT, HEAVY-DUTY UTILITY GLOVES IN THE INSTRUMENT PROCESSING AREA IN THE DENTAL HEALTHCARE SETTING. HU-FRIEDY LILAC UTILITY GLOVES -#40-060- ARE IDENTIFIED BY HU-FRIEDY ON ITS WEBSITE AND MARKETS THESE GLOVES THROUGH DENTAL SUPPLY COMPANIES AS PUNCTURE-RESISTANT UTILITY GLOVES. THE PACKAGING FOR THESE GLOVES STATES THAT THEY ARE "PUNCTURE RESISTANT." I EMAILED HU-FRIEDY TO DETERMINE IF THESE GLOVES ARE CERTIFIED AS PUNCTURE-RESISTANT BY OSHA AND THE CDC. THEY NEVER RESPONDED TO MY INFO REQUEST. CLINICALLY, I KNOW THAT THESE GLOVES ARE NOT PUNCTURE-RESISTANT: A 20 GAUGE OR 23 GAUGE NEEDLE PASSES THROUGH THEM WITH VIRTUALLY NO RESISTANCE. THE USE OF NON-PUNCTURE-RESISTANT UTILITY GLOVES BY HEALTHCARE WORKERS BELIEVING THAT THESE GLOVES ARE PUNCTURE-RESISTANT WHEN THEY ARE NONCOMPLIANT WITH OSHA AND THE CDC REGULATIONS IS NOT ONLY FRAUDULENT, IT IS UNHEALTHY AND DANGEROUS. THE FDA SHOULD STOP HU-FRIEDY FROM MISREPRESENTING THESE GLOVES AS PUNCTURE RESISTANT AND THEY SHOULD RECALL THESE GLOVES FOR THE SAFETY HAZARD THAT THEY PRESENT TO HEALTHCARE WORKERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UTILITY GLOVE 40-060 INSTRUMENT PROCESSING UTILITY GLOVE LYY HU-FRIEDY MFG CO., INC. 40-060

    Patients

    Seq Age Sex Outcome Treatment
    1