BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLENE SUTURE 30IN(75CM) 2-0 BLU

    MDR report key: 18841605 · Received March 5, 2024

    Report

    Report Number
    2210968-2024-02424
    Event Type
    Malfunction
    Date Received
    March 5, 2024
    Date of Event
    February 15, 2024
    Report Date
    May 3, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    UDI-DI
    10705031238244
    PMA / PMN Number
    K133356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (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. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: WERE THERE ANY UNEXPECTED OUTCOMES OR COMPLICATIONS AS A RESULT OF THE PROLONGED SURGERY TIME? ANS: NO. WERE THERE ANY PATIENT CONSEQUENCES? ANS: NO. A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED, AND NO RELATED NON-CONFORMANCES WERE IDENTIFIED. TO DATE IT HAS BEEN REPORTED THAT THE DEVICE WILL NOT BE RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. H6 COMPONENT CODE: G07002 DEVICE NOT RETURNED. RELATED EVENTS CAPTURED VIA: 2210968-2024-02427; 2210968-2024-02429; 2210968-2024-02432; 2210968-2024-02433; 2210968-2024-02434; 2210968-2024-02435; 2210968-2024-02436; 2210968-2024-02437; 2210968-2024-02438.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # PC-(B)(4) DATE SENT TO THE FDA: 5/3/2024 ADDITIONAL INFORMATION: H6 A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED, AND NO RELATED NON-CONFORMANCES WERE IDENTIFIED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SACROCOLPOPEXY PROCEDURE ON (B)(6) 2024; AND A SUTURE WAS USED. THE SUTURE BRANCHED OUT TO TWO STRANDS AFTER PULLING IN A ROBOTIC CASE. THE PROBLEM SUTURE WAS REMOVED WHICH CAUSED A 15 MINUTES OF DELAY TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164952 PROLENE SUTURE 30IN(75CM) 2-0 BLU SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC. RLBESB 10705031238244

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown