BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NSSA

    MDR report key: 6053742 · Received October 25, 2016

    Report

    Report Number
    9612030-2016-00563
    Event Type
    Malfunction
    Date Received
    October 25, 2016
    Report Date
    October 7, 2016
    Manufacturer
    COVIDIEN
    Product Code
    FSM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 10/25/2016. 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 AN ISSUE OCCURRED WITH A LITE HANDLE COVER FROM INSIDE A KIT. THE CUSTOMER REPORTED THAT THE PACK OF TWO LIGHT HANDLE COVERS WERE CRACKED WHEN OPENED FOR USE. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706553 NSSA LITE HANDLE COVER FSM COVIDIEN SA5004

    Patients

    Seq Age Sex Outcome Treatment
    1