BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VICRYL CT UD 90CM M5

    MDR report key: 12456027 · Received September 10, 2021

    Report

    Report Number
    2210968-2021-08312
    Event Type
    Malfunction
    Date Received
    September 10, 2021
    Date of Event
    July 5, 2021
    Report Date
    July 5, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 10/18/2021. H6 COMPONENT CODE: G07002 - DEVICE NOT RETURNED. 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, AND NO NON-CONFORMANCES WERE IDENTIFIED. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: COULD YOU PLEASE SPECIFY HOW MANY DEVICES WERE OBSERVED WITH HAVING "NEEDLE AND SUTURE SEPARATION" IN LOT NUMBER QPBCJKQ0 AND HOW MANY IN LOT NUMBER QPBBXWQ0? FROM QPBBXWQ0 28 PCS WERE FAULTY, AND FROM QPBCJKQ0 7 PCS WERE OBSERVED WITH THE PROBLEM. HOW WAS THE PROCEDURE COMPLETED? WITH SAME LIKE SUTURES.

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. EVENTS REPORTED VIA: 2210968-2021-08314, 2210968-2021-08310, 2210968-2021-08318, 2210968-2021-08317, 2210968-2021-08325, 2210968-2021-08315, 2210968-2021-06884, 2210968-2021-06885, 2210968-2021-06886, 2210968-2021-08319, 2210968-2021-08320, 2210968-2021-08321, 2210968-2021-08322, 2210968-2021-08323, 2210968-2021-08324, 2210968-2021-083.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1351805 VICRYL CT UD 90CM M5 SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. QPBCJKQ0

    Patients

    Seq Age Sex Outcome Treatment
    1