BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILK BRD BLK 15X60CM M2.5

    MDR report key: 17811515 · Received September 25, 2023

    Report

    Report Number
    2210968-2023-07032
    Event Type
    Malfunction
    Date Received
    September 25, 2023
    Date of Event
    August 21, 2023
    Report Date
    October 23, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAP
    PMA / PMN Number
    K946173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 10/23/2023. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED: THE SURGERY TIME WAS PROLONGED FOR 1 HOUR. NO SUBSEQUENT ADVERSE EVENT REPORT WAS RECEIVED. 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: 9/25/2023. 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 LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. THE FOLLOWING ADDITIONAL INFORMATION REQUESTED, BUT UNAVAILABLE: - WERE THERE ANY UNEXPECTED OUTCOMES OR COMPLICATIONS AS A RESULT OF THE PROLONGED SURGERY TIME? - HOW LONG (IN MINUTES) DID THE SURGERY PROLONG? - WHAT TISSUE WAS BEING SUTURED WHEN THE EVENT OCCURRED? - 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? - QUANTITY OF BLOOD LOSS? - PATIENT WEIGHT? - WAS THERE ANY MEDICAL OR SURGICAL INTERVENTION PERFORMED (PRODUCT REMOVED; RE-OPERATION; RE-SUTURING; RE-CLOSURE; DRAINAGE)? IF SO, PLEASE SPECIFY. - COULD YOU TELL ME IF THERE WAS A PRESCRIPTION FOR STEROIDS OR ANTIBIOTICS FOR THE PATIENT'S RECOVERY? IF YES, PLEASE PROVIDE MEDICATION NAME, ROUTE AND DOSE. - PLEASE PROVIDE THE SOURCE OR NAME OF PERSON PROVIDING ANSWERS TO FOLLOW-UP QUESTIONS (NOT THE PERSON RELAYING/SUBMITTING ANSWERS TO LOC OR CHU). --CONTACTED WITH THE SALES REP TODAY VIA PHONE, PLEASE REFER TO THE EVENT DESCRIPTION AND OTHER INFORMATION REQUESTED IS UNKNOWN. 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. RELATED REPORTS: 2210968-2023-07033.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REPAIR OF ANTERIOR AND POSTERIOR VAGINAL WALL PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE PATIENT WAS ADMITTED FOR TREATMENT DUE TO "STRESS URINARY INCONTINENCE" AND UNDERWENT REPAIR OF ANTERIOR AND POSTERIOR VAGINAL WALLS SURGERY ON THE THIRD DAY OF ADMISSION DURING THE PROCEDURE, WHEN THE DOCTOR SUTURED THE SURGICAL INCISION AND TIED THE SUTURE, THE SUTURE BROKE, CAUSING THE INCISION TO BLEED CONTINUOUSLY. RE PIERCING THE SAME BATCH AND SPECIFICATION OF SUTURE WAS ALSO EASY TO BREAK, RESULTING IN FAILED HEMOSTASIS OF THE SURGICAL INCISION AND PROLONGED SURGICAL TIME. FINALLY, A NEW SUTURE WAS REPLACED TO COMPLETE THE SURGICAL INCISION SUTURING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1267955 SILK BRD BLK 15X60CM M2.5 SUTURE, NONABSORBABLE, SILK GAP ETHICON INC. RG4AZ

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female