BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VCL CT BRD VIO 27IN 1 S/A CT-1

    MDR report key: 11257804 · Received February 1, 2021

    Report

    Report Number
    2210968-2021-00852
    Event Type
    Malfunction
    Date Received
    February 1, 2021
    Date of Event
    January 1, 2020
    Report Date
    January 7, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031039056
    PMA / PMN Number
    K022269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: FOR THE CASE OF THE SECOND SURGEON, COULD YOU PLEASE PROVIDE THE FOLLOWING INFORMATION OF THE EVENT: PROCEDURE NAME AND DATE? N/K. WERE THERE ANY ADVERSE PATIENT CONSEQUENCES? NO. WAS THE ISSUE NOTED WHILST SUTURING OR WHILE BEING TAKEN OUT OF THE PACKET? WHILST SUTURING. HOW WAS THE PROCEDURE COMPLETED? NOT PROVIDED. LOT NUMBER? N/K. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE FREE FROM THE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154667 VCL CT BRD VIO 27IN 1 S/A CT-1 SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. J341H 10705031039056

    Patients

    Seq Age Sex Outcome Treatment
    1