BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3-0 DEXON CE-4 SUTURE NEEDLE

    MDR report key: 18527 · Received December 22, 1994

    Report

    Report Number
    MW1004556
    Event Type
    Malfunction
    Date Received
    December 22, 1994
    Date of Event
    December 5, 1994
    Report Date
    December 9, 1994
    Manufacturer
    DAVIS & GECK, INC.
    Product Code
    GAM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SUTURE NEEDLE BROKE OFF DURING CASE, MD INDICATED THAT THERE WAS NO UNDUE PRESSURE USED WHILE SUTURING. REQUIRED FLUOROSCOPY TO RETRIEVE BROKEN END.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3-0 DEXON CE-4 SUTURE NEEDLE SUTURE NEEDLE GAM DAVIS & GECK, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 *