BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILK SUTURE 30"(75CM) 2-0 BLK

    MDR report key: 11636179 · Received April 8, 2021

    Report

    Report Number
    2210968-2021-03160
    Event Type
    Malfunction
    Date Received
    April 8, 2021
    Date of Event
    March 17, 2021
    Report Date
    March 18, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAP
    UDI-DI
    10705031044388
    PMA / PMN Number
    K946173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DATE SENT TO THE FDA: 05/14/2021. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH QEBBRB, K833H14 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. DATE SENT TO THE FDA: 05/14/2021. 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 · 1

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WHAT WAS DONE TO RETRIEVE THE NEEDLE? FOR EXAMPLE, SWITCHED TO AND OPEN PROCEDURE, SECOND SURGERY? WAS ADDITIONAL DISSECTION REQUIRED IN OTHER ORGANS/TISSUES OTHER THAN THE TARGET TISSUE? WAS THERE ANY CHANGE IN THE PATIENT¿S POST-OPERATIVE CARE DUE TO THE PROLONGED PROCEDURE? THE SURGEON WAS ABLE TO RETRIEVE THE NEEDLE LAPAROSCOPICALLY IN THE SAME PROCEDURE WITHOUT FURTHER TISSUE DISSECTION. THERE WAS NOT ANY CHANGE IN THE PATIENT¿S POST-OPERATIVE CARE DUE TO PROLONGED EXPOSURE. DR (B)(6) SAW THE PATIENT YESTERDAY AND SHE IS DOING FINE. SHE HAS SOME MUSCULOSKELETAL PAIN IN HER LEG BUT HE BELIEVES THAT IS MOST LIKELY DUE TO HER LEG POSITIONING ON THE TABLE. 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 · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LAP GASTRIC SLEEVE SURGERY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT THE NEEDLE CAME OFF OF THE SUTURE WITHIN THE PATIENT'S ABDOMEN. AN X-RAY WAS PERFORMED AND THE NEEDLE WAS RETRIEVE FROM THE PATIENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534772 SILK SUTURE 30"(75CM) 2-0 BLK SUTURE, NONABSORBABLE, SILK GAP ETHICON INC. K833H QEBBRB 10705031044388

    Patients

    Seq Age Sex Outcome Treatment
    1