BEUDAMED
    FDA Adverse Event Injury Summary report: N

    25G SOFT TIP CANNULA, DSP, 0.8MM

    MDR report key: 5903431 · Received August 22, 2016

    Report

    Report Number
    MW5064321
    Event Type
    Injury
    Date Received
    August 22, 2016
    Date of Event
    April 19, 2016
    Report Date
    August 22, 2016
    Manufacturer
    ALCON MEDICAL PRODUCT
    Product Code
    HMX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE TIP OF AN EXTRUSION CANNULA, 25G SOFT TIP CANNULA, DSP, 0.8MM, ALCON, INC. , BROKE OFF DURING A SURGICAL PROCEDURE (PARS PLANA VITRECTOMY) AND WAS NOT ABLE TO BE VISUALIZED UNTIL 22 DAYS POST-OP WHEN THE INTRA-VITREAL STEROID WAS COMPLETELY ABSORBED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547262 25G SOFT TIP CANNULA, DSP, 0.8MM 25G SOFT TIP CANNULA, DSP, 0.8MM HMX ALCON MEDICAL PRODUCT 994709

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention