BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3612 LITE GLOVE

    MDR report key: 6096657 · Received November 11, 2016

    Report

    Report Number
    9612030-2016-00639
    Event Type
    Malfunction
    Date Received
    November 11, 2016
    Report Date
    November 2, 2016
    Manufacturer
    COVIDIEN
    Product Code
    FMC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDER WAY; UPON COMPLETION THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2016 THAT THE CUSTOMER EXPERIENCED AN ISSUE WITH TWO CARTONS OF LITE GLOVES. THE CUSTOMER REPORTS THAT THE GLOVES TEAR WHEN PULLED OVER THE LITE GLOVE HANDLE DURING SET UP. NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748486 3612 LITE GLOVE LIGHT GLOVE FMC COVIDIEN 31140257

    Patients

    Seq Age Sex Outcome Treatment
    1