BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VCL CT BRD VIO 30IN 2-0 S/A LH

    MDR report key: 19825757 · Received July 25, 2024

    Report

    Report Number
    2210968-2024-07633
    Event Type
    Malfunction
    Date Received
    July 25, 2024
    Date of Event
    January 1, 2024
    Report Date
    July 25, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031129146
    PMA / PMN Number
    K022269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H6 COMPONENT CODE: G07002 DEVICE NOT RETURNED. 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE COULD NOT FULLY FULFILL ITS FUNCTION AS A RESULT OF THE THREAD BREAKING AND NEEDLE BENDING DURING THE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365302 VCL CT BRD VIO 30IN 2-0 S/A LH SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. UBBCCBR0 10705031129146

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown