BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERS GRN 30IN 2-0 S/A V-7

    MDR report key: 13656879 · Received March 2, 2022

    Report

    Report Number
    2210968-2022-01453
    Event Type
    Malfunction
    Date Received
    March 2, 2022
    Date of Event
    January 26, 2022
    Report Date
    April 25, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT: WAS THE NEEDLE PIECE REMOVED FROM THE PATIENT DURING THE SAME PROCEDURE? WHAT TISSUE/LOCATION WAS SUTURING WHEN PULL OFF OCCURRED? WERE THERE ANY UNEXPECTED OUTCOMES OR COMPLICATIONS AS A RESULT OF THIS SUTURE NEEDLE PULL OFF EVENT? PRODUCT CODE? LOT NUMBER? PROCEDURE DATE? DEVICE RETURN STATUS/FOLLOW UP? 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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 4/25/2022. H6 COMPONENT CODE: G07002 NO DEVICE RETURN. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4) DATE SENT TO THE FDA: 4/5/2022 ADDITIONAL INFORMATION: D4, G1 ADDITIONAL INFORMATION WAS REQUESTED, THE FOLLOWING WAS OBTAINED: WAS THE NEEDLE PIECE REMOVED FROM THE PATIENT DURING THE SAME PROCEDURE? THE NEEDLE PIECE WAS FALLEN INTO THE PATIENT AND WAS REMOVED FROM THE PATIENT DURING THE SAME PROCEDURE. WHAT TISSUE/LOCATION WAS SUTURING WHEN PULL OFF OCCURRED? FASCIA OF THE RECTUS ABDOMINIS MUSCLES WERE THERE ANY UNEXPECTED OUTCOMES OR COMPLICATIONS AS A RESULT OF THIS SUTURE NEEDLE PULL OFF EVENT? NO. PRODUCT CODE? PRODUCT CODE R964H (MERSILENE 2/0) LOT NUMBER? RJBELS PROCEDURE DATE? (B)(6) 2022 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PROSTHESIS FOR THE HERNIA PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BECAME DETACHED FROM THE NEEDLE. NEED TO USE THE AMPLIFIER TO USE THE SCOPY TO RETRIEVE THE NEEDLE IN THE SURGICAL FIELD. INCIDENT THAT COULD HAVE HAD SERIOUS CONSEQUENCES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1364318 MERS GRN 30IN 2-0 S/A V-7 SUTURE, NONABSORBABLE, SYNTHETIC GAT ETHICON INC. R964H RJBELS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown