BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGUARD

    MDR report key: 508868 · Received January 21, 2004

    Report

    Report Number
    MW1030926
    Event Type
    Injury
    Date Received
    January 21, 2004
    Report Date
    January 21, 2004
    Manufacturer
    PROTECH LEADED EYEWEAR, INC.
    Product Code
    IWP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D 5/27/04: THERE IS VERY LITTLE FOR MFR TO GO ON TO GIVE A CONCLUSIVE ANSWER, RELATIVE TO THE STATED MALFUNCTION. UNFORTUNATELY, THE ONLY INFO ON THE PRODUCT IS THE TRADE NAME. THERE IS NO LOT#, EXPIRATION DATE, NOR WAS MFR GIVEN A SAMPLE BACK TO DETERMINE A MALFUNCTION AND CAUSE IF THERE WAS ONE. THE RELEVANT TESTS AND LABORATORY DATA HAS BEEN CROSSED OUT, THEREFORE MFR IS NOT ABLE TO CONFER WITH THIS LABORATORY TO DETERMINE HOW BAD THE STATED MALFUNCTION WAS. MFR DOES MAINTAIN A CROSS SECTION OF ALL THE LOT# PRODUCED, BUT AGAIN WITHOUT KNOWING WHAT LOT# WAS USED IN THIS REPORT MFR CANNOT GO BACK TO SAMPLES AND TEST FOR ABNORMALITIES. MFR CAN ONLY DO RANDOM SAMPLE TEST OF THE ATTENUATIVE VALUE OF GLOVES MFR HAS NOW, MFR WILL SUBMIT SAMPLES TO AN INDEPENDENT LABORATORY AND SEND THE FOLLOW UP ATTENUATIVE RESULTS WHEN IT IS DONE. MFR WOULD LIKE TO ALSO MENTION, THAT THE OUT COMES DUE TO ADVERSE EVENT ARE GREATLY OVERSTATED. IF A RADIATION REDUCING GLOVE (ANY RADIATION REDUCING GLOVE) FAILED TO PROTECT AT THE LEVEL STATED, DURING ONE USER OR IN FACT A NUMBER OF USES) HOSPITALIZATION, DISABILITY AND PERMANENT IMPAIRMENT WOULD NOT OCCUR.

    Description of Event or Problem · 1

    X-RAY RADIATION REDUCING GLOVES TO BE USED IN ALL HOSPS DURING FLUOROSCOPIC PROCEDURE TO PROTECT DR'S HANDS FROM SCATTERED RADIATION DO NOT ATTENUATE SCATTERED RADIATION AS CLAIMED VERIFIED BY OSHA REPORT OF 12.30.03.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGUARD RADIATION REDUCING GLOVES BASED ON LEAD IWP PROTECH LEADED EYEWEAR, INC. PROGUARD RR-1,PROGUA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization| R| S