BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WI-75 E/KM CONTRA ANG. 20

    MDR report key: 8721856 · Received June 21, 2019

    Report

    Report Number
    0001038806-2019-00563
    Event Type
    Injury
    Date Received
    June 21, 2019
    Report Date
    June 21, 2019
    Manufacturer
    BIOMET 3I
    Product Code
    EGS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CONTRA ANGLE HAND PIECE (10207557) SEIZED DURING THE PROCEDURE. THE PATIENT HAD TO BE SENT HOME AND RESCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514898 WI-75 E/KM CONTRA ANG. 20 HAND PIECE EGS BIOMET 3I 03665

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention