BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAYO-HEGAR NEEDLE DRIVER

    MDR report key: 5778204 · Received July 6, 2016

    Report

    Report Number
    MW5063281
    Event Type
    Injury
    Date Received
    July 6, 2016
    Date of Event
    June 8, 2016
    Report Date
    June 29, 2016
    Manufacturer
    SKLAR SURGICAL INSTRUMENTS
    Product Code
    KOA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MAYO-HEGAR NEEDLE DRIVER BROKE DURING USE. NEEDLE WAS BEING RELEASED AND METAL PIECE POPPED OFF ONTO MAYO STAND. NEEDLE DRIVER REMOVED FROM STERILE FIELD AND REPORTED AN UNSAFE. MANUFACTURER: PLEASE NOTE THAT WE DO NOT SEND PRODUCTS TO THE MFR, BUT YOU MAY ARRANGE FOR PICK-UP BY CALLING MY NUMBER BELOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427500 MAYO-HEGAR NEEDLE DRIVER NEEDLE DRIVER KOA SKLAR SURGICAL INSTRUMENTS

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention