BEUDAMED
    FDA Adverse Event Summary report: N

    COATED VICRYL VIOLET BRADED SUTURE - 35MM 1/2 C

    MDR report key: 3121852 · Received May 15, 2013

    Report

    Report Number
    MW5030215
    Date Received
    May 15, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 15, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    RI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A RIGHT L5-S1 HEMI-LAMINITOMY/DISKECTOMY (MINOR) AND RIGHT L5/S1 HEMI-LAMINOTOMY/DISKECTOMY (MAJOR). DURING THE PROCEDURE OPERATING ROOM TECH REPORTED PIECE OF NEEDLE MISSING (BROKE OFF).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215006 COATED VICRYL VIOLET BRADED SUTURE - 35MM 1/2 C COATED VICRYL VIOLET BRADED SUTURE - 35MM 1/2 C GAM ETHICON, INC. J740D.P34 EK2557

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR