BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARS 1800 LAF

    MDR report key: 5922517 · Received September 1, 2016

    Report

    Report Number
    1216677-2016-00036
    Event Type
    Malfunction
    Date Received
    September 1, 2016
    Date of Event
    April 13, 2016
    Report Date
    May 3, 2016
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    PUB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT AS PER REQUEST FROM FDA MEDWATCH PROGRAM .

    Description of Event or Problem · 1

    "REMOVED THE MOTOR -BURNT MY HAND." (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575538 MARS 1800 LAF MARS 1800 LAF PUB COOPERSURGICAL, INC. WM1800 2014-12-03-0348

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other