BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EB EXC GRN 30IN 2-0 S/A SH

    MDR report key: 20137489 · Received September 4, 2024

    Report

    Report Number
    2210968-2024-09274
    Event Type
    Malfunction
    Date Received
    September 4, 2024
    Date of Event
    January 1, 2024
    Report Date
    September 4, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    UDI-DI
    10705031058033
    PMA / PMN Number
    K946173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED BY SALES REP THAT THE OR TEAM OPENED A PACK OF X833H AND THERE HAS BEEN TWO EACHES THAT WERE DOUBLE ARMED WHEN THEY WERE SUPPOSED TO BE SINGLE ARMED. THERE WAS NO PATIENT INVOLVEMENT. DEVICE AVAILABILITY UNKNOWN. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1385841 EB EXC GRN 30IN 2-0 S/A SH SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC. TGBEBH 10705031058033

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown