BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STACLEAR

    MDR report key: 14934156 · Received July 5, 2022

    Report

    Report Number
    MW5110672
    Event Type
    Malfunction
    Date Received
    July 5, 2022
    Date of Event
    June 9, 2022
    Report Date
    June 30, 2022
    Manufacturer
    TRIBOFILM RESEARCH, INC.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2756652 STACLEAR SYRINGE, PISTON FMF TRIBOFILM RESEARCH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female