BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXON

    MDR report key: 58184 · Received December 20, 1996

    Report

    Report Number
    58184
    Event Type
    Injury
    Date Received
    December 20, 1996
    Date of Event
    December 18, 1996
    Report Date
    December 19, 1996
    Manufacturer
    DAVIS & GECK, INC.
    Product Code
    GAB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT WAS UNDERGOING A SCHEDULED C/SECTION. WHEN THE PHYSICIAN WAS SUTURING THE UTERUS, THE SUTURE NEEDLE BROKE OFF IN THE UTERUS. THE PT LOST SUBSTANTIAL AMOUNT OF BLOOD DURING THE TIME IT TOOK TO RETRIEVE THE NEEDLE. EXPIRATION DATE 11/1/00.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXON SUTURE GAB DAVIS & GECK, INC. 7266-71 943362

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention