BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUTURE, ABSORBABLE, NATURAL

    MDR report key: 18551791 · Received January 22, 2024

    Report

    Report Number
    18551791
    Event Type
    Other
    Date Received
    January 22, 2024
    Date of Event
    August 10, 2023
    Report Date
    September 29, 2023
    Manufacturer
    ETHICON, LLC.
    Product Code
    GAL
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT IN EP LAB FOR A GENERATOR CHANGE OF A PERMANENT PACEMAKER (PPM). WHILE SUTURING THE LEFT CHEST INCISION SITE, THE SUTURE BROKE, AND A PORTION OF THE NEEDLE REMAINED IN THE POCKET. THE PHYSICIAN HAD TO REOPEN THE INCISION SITE AND REMOVE THE GENERATOR TO RETRIEVE THE BROKEN SUTURE. THE RETRIEVAL OF THE BROKEN SUTURE NEEDLE WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2064944 SUTURE, ABSORBABLE, NATURAL GAL ETHICON, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown