BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILK BRD BLK 15X60CM M2.0

    MDR report key: 17441667 · Received August 2, 2023

    Report

    Report Number
    2210968-2023-05546
    Event Type
    Malfunction
    Date Received
    August 2, 2023
    Date of Event
    July 3, 2023
    Report Date
    September 29, 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). 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. 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. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: ¿ ARE THERE PICTURES OF THE REPORTED FAILURE AVAILABLE THAT COULD BE FORWARDED FOR REVIEW? ¿ ARE THERE STERILE SAMPLES FROM THE REPORTED FINISHED GOODS LOT NUMBER AVAILABLE FOR TESTING? ¿ PLEASE RETURN SAMPLES WITH THE CORZA MEDICAL COMPLAINT NUMBER CLEARLY MARKED ON THE OUTSIDE BOX VIA CARRIER UPS ACCOUNT #4E146X WORLDWIDE SAVER EXPRESS OR GROUND TO THE FOLLOWING ADDRESS: CORZA MEDICAL 1690 BRANDYWINE SUITE C CHULA VISTA, CA 91911 ----------CONTACTED WITH THE SALES REP TODAY VIA PHONE, PLEASE REFER TO THE EVENT DESCRIPTION AND OTHER INFORMATION REQUESTED IS UNKNOWN. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, AFTER THE SURGERY, WHEN THE DOCTOR SUTURED THE PATIENT, THE SUTURE WAS INTERRUPTED AND MULTIPLE SUTURE WERE REPLACED TO COMPLETE THE SUTURE. THE SURGEON OPINED THAT POOR SUTURE TOUGHNESS DURING OR AFTER SUTURING CAN PROLONG THE SUTURING TIME, INCREASE PATIENT PAIN, AND IN SEVERE CASES, CAUSE INFECTION. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1261012 SILK BRD BLK 15X60CM M2.0 SUTURE, NONABSORBABLE, SILK GAP ETHICON INC. RP3AB

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female