BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILK SUTURE UNKNOWN PRODUCT

    MDR report key: 21178768 · Received January 17, 2025

    Report

    Report Number
    2210968-2025-00700
    Event Type
    Malfunction
    Date Received
    January 17, 2025
    Date of Event
    November 26, 2024
    Report Date
    January 17, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAP
    PMA / PMN Number
    K946173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #(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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. H6 COMPONENT CODE: G07002 DEVICE NOT RETURNED. 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: PATIENT CONSEQUENCES? IF YES, PLEASE SPECIFY. IT WAS REPORTED THAT THE PRODUCT CODE OF THE DEVICE IS N231110, HOWEVER IT WAS NOT RECOGNIZED IN OUR SYSTEM. PLEASE CONFIRM THE CORRECT PRODUCT CODE. LOT NUMBER?

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A DEBRIDEMENT AND SUTURING PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHEN KNOTTED. VIOLENT USE WAS RULED OUT, AND THE SUTURE WAS IMMEDIATELY REPLACED TO SUTURE THE WOUND. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1141357 SILK SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SILK GAP ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male