BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXON SUTURE AND NEEDLE

    MDR report key: 18652 · Received December 30, 1994

    Report

    Report Number
    MW1004618
    Event Type
    Malfunction
    Date Received
    December 30, 1994
    Date of Event
    December 6, 1994
    Report Date
    December 14, 1994
    Manufacturer
    DAVIS & GECK, INC.
    Product Code
    GAM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT HAD CESAREAN SECTION. DURING THE SURGERY THE TIP OF NEEDLE BROKE OFF. DR HAD THE PT X-RAYED AND THE NEEDLE TIP WAS NOT SEEN. PT HAS NOT SUFFERED ANY ADVERSE REACTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR