BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3611 LITE GLOVE

    MDR report key: 5979843 · Received September 27, 2016

    Report

    Report Number
    9612030-2016-00467
    Event Type
    Malfunction
    Date Received
    September 27, 2016
    Report Date
    September 23, 2016
    Manufacturer
    COVIDIEN
    Product Code
    LYU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 9/27/2016. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2016 THAT A CUSTOMER HAD AN ISSUE WITH A LITE GLOVE. THE CUSTOMER REPORTS: LITES GLOVES BREAKS DURING INTRODUCTION ONTO THE HANDLE OF THE OPERATING LAMP RESULTING IN NON STERILIZED OF THE SURGEON IF THE OPERATING LAMP IS TAKEN IN HAND DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632666 3611 LITE GLOVE LITE GLOVE LYU COVIDIEN 31140208 6139100164

    Patients

    Seq Age Sex Outcome Treatment
    1