BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICAL STAINLESS STEEL SUTURE

    MDR report key: 512395 · Received February 23, 2004

    Report

    Report Number
    2210968-2004-00055
    Event Type
    Injury
    Date Received
    February 23, 2004
    Report Date
    January 26, 2004
    Manufacturer
    ETHICON, INC. SAN LORENZO
    Product Code
    GAQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STEEL SUTURE WAS USED FOR A BROKEN WRIST SURGERY. THE SUTURE REPORTEDLY BROKE AS THE SURGEON WAS REMOVING THE SUTURES. AN ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE STEEL PIECES FROM THE WRIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGICAL STAINLESS STEEL SUTURE SUTURE. NON-ABSORBABLE GAQ ETHICON, INC. SAN LORENZO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention