BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3612 LITE GLOVE

    MDR report key: 6305721 · Received February 6, 2017

    Report

    Report Number
    9612030-2017-00058
    Event Type
    Malfunction
    Date Received
    February 6, 2017
    Report Date
    January 19, 2017
    Manufacturer
    COVIDIEN
    Product Code
    LYU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 1/19/2017. 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 1/19/2017 THAT A CUSTOMER HAD AN ISSUE WITH A SYRINGE. THE CUSTOMER STATES THAT THE LITE GLOVES TEARS AT PULLING OVER HANDLE. NO PATIENT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88867 3612 LITE GLOVE LITE GLOVE LYU COVIDIEN 31140257 6158100264

    Patients

    Seq Age Sex Outcome Treatment
    1