BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLO, 20GA, STRAIGHT, AMO

    MDR report key: 2815192 · Received October 22, 2012

    Report

    Report Number
    3019924-2012-00044
    Event Type
    Injury
    Date Received
    October 22, 2012
    Report Date
    October 22, 2012
    Manufacturer
    MICROSURGICAL TECHNOLOGY, INC.
    Product Code
    KYG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    WHILE USING A SOLO I/A HANDPIECE THE SURGEON EXPERIENCED A CAPSULE RUPTURE. THE PROCEDURE WAS COMPLETED AS PLANNED. THERE WERE TWO CAPSULE RUPTURES REPORTED, THIS IS THE FIRST OF TWO REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLO, 20GA, STRAIGHT, AMO IRRIGATION/ASPIRATION HANDPIECE KYG MICROSURGICAL TECHNOLOGY, INC. OPOIA20STR 044004

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention