BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIZE MEDIUM NITRILE EXAM GLOVES HIGH FIVE PERFORMANCE GLOVES

    MDR report key: 4253536 · Received November 12, 2014

    Report

    Report Number
    MW5039045
    Event Type
    Malfunction
    Date Received
    November 12, 2014
    Date of Event
    November 7, 2014
    Report Date
    November 12, 2014
    Manufacturer
    BOSMA ENTERPRISES
    Product Code
    LYY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FOREIGN OBJECT, WHICH APPEARS TO BE A RUSTY WASHER, WAS FOUND BY STAFF INSIDE THE BOX OF NITRILE EXAM GLOVES. THE OBJECT WAS STUCK TO THE OUTSIDE OF ONE OF THE GLOVES INSIDE THE BOX. THERE WAS ALSO A RUSTY RESIDUE FROM THE WASHER ON THE GLOVE. WILL SEND TO MANUFACTURER FOR ANALYSIS. SEE SCANNED PAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729026 SIZE MEDIUM NITRILE EXAM GLOVES HIGH FIVE PERFORMANCE GLOVES LYY BOSMA ENTERPRISES 72-10502 15073-261407

    Patients

    Seq Age Sex Outcome Treatment
    1