BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURE COUNT

    MDR report key: 18013 · Received November 29, 1994

    Report

    Report Number
    MW1004170
    Event Type
    Malfunction
    Date Received
    November 29, 1994
    Date of Event
    November 10, 1994
    Report Date
    November 11, 1994
    Manufacturer
    KLEEN TEST PRODUCTS
    Product Code
    MMK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    EMPLOYEE WAS CLOSING BOX CONTAINING USED SUTURE NEEDLES. AS EMPLOYEE CLOSED THE BOX WITH HER HANDS A SUTURE NEEDLE PUNCTURED THE CONTAINER. THE NEEDLE ALSO PUNCTURED THE SKIN OF HER RIGHT PALM. THE EMPLOYEE WAS TREATED IN THE EMPLOYEE HEALTH CLINIC. SHE WAS TESTED FOR HIV.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURE COUNT SUTURE DISPOSAL CONTAINER MMK KLEEN TEST PRODUCTS 920535

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other