BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELASTYREN

    MDR report key: 145932 · Received January 6, 1998

    Report

    Report Number
    MW4002109
    Event Type
    Injury
    Date Received
    January 6, 1998
    Report Date
    January 5, 1998
    Manufacturer
    ECI MEDICAL TECHNOLOGIES, INC.
    Product Code
    KGO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    RPTR WISHES TO REPORT A MAJOR DEFECT IN BOTH ELASTYREN AND ELASTY LITE SURGICAL GLOVES. THESE GLOVES TEAR IN MULTIPLE PLACES WITH A MINIMUM OF STRESS DURING SURGERY. THIS DEFECT ENDANGERS BOTH THE PT AND THE SURGEON. RPTR CALLED CO'S OFFICE TO REPORT THIS DEFECT AND CO'S PEOPLE TOLD RPTR THAT CO KNEW ABOUT THE DEFECT BUT SENT THE GLOVES ANYWAY TO AVOID DELAYS. CO THEN SENT A REPLACEMENT, ELASTYLITE, WHICH WAS BETTER BUT STILL DEFECTIVE IN THAT THEY RIPPED TOO EASILY. RPTR BELIEVES THAT THIS IS A SERIOUS PROBLEM AND THAT CO'S GLOVES SHOULD BE TAKEN OFF THE MARKET. RPTR REQUESTED A FULL REFUND. RPTR CONSIDERS BLOOD TO BE AS DANGEROUS AS PLUTONIUM AND IS PERSONALLY AND PROFESSIONALLY EXTREMELY UPSET BY CO'S POOR PRODUCT EXPOSING THEM TO THE RISKS OF AIDS AND HEPATITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELASTYREN SURGEONS GLOVES KGO ECI MEDICAL TECHNOLOGIES, INC. NA 96404-D
    2 ELASTY LITE SURGICAL GLOVES SURGEONS GLOVE KGO ECI MEDICAL TECHNOLOGIES, INC. NA 97279-D

    Patients

    Seq Age Sex Outcome Treatment
    1 NA