BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON ABSORBABLE SURGICAL SUTURE

    MDR report key: 16275560 · Received January 31, 2023

    Report

    Report Number
    2210968-2023-00690
    Event Type
    Malfunction
    Date Received
    January 31, 2023
    Date of Event
    January 11, 2023
    Report Date
    January 31, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAP
    PMA / PMN Number
    K946173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. 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 INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED VIA: SALES REP INFORMED 7 CODES WERE USED IN 2 DIFFERENT PROCEDURES. OUT OF WHICH 3 CODES WERE CAPTURED IN (B)(4) USED IN ONE SURGERY. TO CAPTURE OTHER 4 CODES(2ND SURGERY) THIS COMPLAINT HAS BEEN CREATED EVENTS REPORTED VIA: 2210968-2023-00682, 2210968-2023-00683, 2210968-2023-00684, 2210968-2023-00685,2210968-2023-00686,2210968-2023-00687, 2210968-2023-00688, 2210968-2023-00689, 2210968-2023-00693.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ECTOPIC PREGNANCY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON USED SW214 & SW215 FOR CBD LIGATION IN PROCEDURE, BUT SUTURE WAS BREAKING AFTER 3RD OR 4TH PASS THROUGH TISSUE. NW5036 IS AGAIN BREAKING WHILE CLOSURE OF SKIN-SUB Q CLOSURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402016 NON ABSORBABLE SURGICAL SUTURE SUTURE, NONABSORBABLE, SILK GAP ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown