BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MST ALLEGRO SINGLE USE SILICONE I/A TIP

    MDR report key: 5099493 · Received September 24, 2015

    Report

    Report Number
    3019924-2015-00031
    Event Type
    Injury
    Date Received
    September 24, 2015
    Report Date
    September 22, 2015
    Manufacturer
    MICROSURGICAL TECHNOLOGY INC
    Product Code
    HMX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED WITH THE INNER CANNULA DISLODGED FROM THE SILICONE SLEEVE.

    Description of Event or Problem · 1

    WHILE USING AN MST I/A TIP THE SURGEON EXPERIENCE A CAPSULE TEAR. NO VITRECTOMY WAS PERFORMED AND THE PATIENT WAS REPORTED AS BEING OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633442 MST ALLEGRO SINGLE USE SILICONE I/A TIP OPHTHALMIC CANNULA HMX MICROSURGICAL TECHNOLOGY INC AT-0001-R 069196

    Patients

    Seq Age Sex Outcome Treatment
    1 Other