BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SFXSPI MCL+ BI UD 12IN2 3-0 DA PS-2 PR

    MDR report key: 21162334 · Received January 15, 2025

    Report

    Report Number
    2210968-2025-00565
    Event Type
    Malfunction
    Date Received
    January 15, 2025
    Date of Event
    January 1, 2024
    Report Date
    January 15, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031464315
    PMA / PMN Number
    K192580
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY 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: - WAS THERE ANY ADVERSE CONSEQUENCE ASSOCIATED WITH THE PATIENT? - WHAT IS THE LOT NUMBER? THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR PART 803, PART 4 SUBPART B. 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPY PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. THE THREAD TORN WHEN STITCHING BACK. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2116383 SFXSPI MCL+ BI UD 12IN2 3-0 DA PS-2 PR SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID GAM ETHICON INC. 10705031464315

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown