BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CASTROVIEJO NEEDLE HOLDERS, 5 1/2", 10MM SMO

    MDR report key: 964883 · Received May 9, 2007

    Report

    Report Number
    2430952-2007-00013
    Event Type
    Malfunction
    Date Received
    May 9, 2007
    Report Date
    May 8, 2007
    Manufacturer
    SCHMID MEDIZINTECHNIK GMBH
    Product Code
    FHQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR HAS BEEN NOTIFIED OF THE REPORTED COMPLAINT.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTD THE TIP OF THE INSTRUMENT BROKE OFF WHILE GRASPING SUTURE DURING AN EYE PLASTIC PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CASTROVIEJO NEEDLE HOLDERS, 5 1/2", 10MM SMO NEEDLE HOLDER FHQ SCHMID MEDIZINTECHNIK GMBH * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *