BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STACLEAR SYRINGE

    MDR report key: 14934128 · Received July 5, 2022

    Report

    Report Number
    MW5110671
    Event Type
    Malfunction
    Date Received
    July 5, 2022
    Date of Event
    June 16, 2022
    Report Date
    June 30, 2022
    Manufacturer
    TRIBOFILM RESEARCH, INC.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    NEEDLE ON PRE-PACKAGED AVASTIN SYRINGE INSUFFICIENT TO APPROPRIATELY PUNCTURE SCLERA AND ADMINISTER INTRAVITREAL MEDICATION. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2756651 STACLEAR SYRINGE SYRINGE, PISTON FMF TRIBOFILM RESEARCH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Male