BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMFS010-002 AND OMFS010-003

    MDR report key: 6091254 · Received November 9, 2016

    Report

    Report Number
    6091254
    Event Type
    Malfunction
    Date Received
    November 9, 2016
    Date of Event
    September 24, 2016
    Report Date
    October 31, 2016
    Manufacturer
    UNK
    Product Code
    EKD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TWO WIRE CUTTERS BROKE WHILE BEING USED ON PATIENT. THERE WAS NO INJURY TO THE PATIENT. THE WIRE CUTTERS WERE IMMEDIATELY REMOVED FROM THE FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742811 OMFS010-002 AND OMFS010-003 WIRE CUTTER EKD UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR NO