BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLENE

    MDR report key: 24729417 · Received March 30, 2026

    Report

    Report Number
    2210968-2026-03256
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    February 18, 2026
    Report Date
    April 29, 2026
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    UDI-DI
    10705031015470
    PMA / PMN Number
    K133356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 3/30/2026 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, 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. THE FOLLOWING INFORMATION WAS REPORTED: ACCOUNT: C M I D C (PLEASE REFER TO THE ATTACHED EMAIL) EVENT DATE: 18-FEBRUARY-2026 PRODUCT CODE: 8425H ACTION TAKEN:.. "REQUEST SUTURES, NEWS OF THE DEVICE IS REPORTED FOR REDIRECTION TO THE SUPPLIER" ... AW5713: ETHICON ## AFFECTED SIDE: NOT APPLICABLE ## AFFECTED QUANTITY: (B)(4) ## QUANTITY AVAILABLE FOR RETURN: 1 LIST THE J&J PRODUCTS THAT WERE USED DURING THE CASE BUT DID NOT CONTRIBUTE TO THE REPORTED EVENT. ## NOT REPORTED*** WAS THERE ANY HARM TO THE REPORTED PATIENT OR USER? ## NO *** WAS THERE A SIGNIFICANT DELAY? ## NO *** IF AVAILABLE, PLEASE PROVIDE THE PRODUCT ORDER NUMBER (PO). ## YES, AVAILABLE I DO NOT HAVE A SHIPPING GUIDE NUMBER, AS I AM WAITING FOR THE RETURN OF THE PRODUCT. *** 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. D4: UDI: THE EXPIRATION DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE.

    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. ADDITIONAL INFORMATION: H6. THE FOLLOWING INFORMATION WAS RECEIVED: I SHARE THE TRACKING NUMBER SENT (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. SUTURE FRAYS, AT THE TIME OF PASSING THE STITCH. HARM OR INJURY PRESENTED TO THE PATIENT: NONE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184114 PROLENE SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC. AW5713 10705031015470

    Patients

    Seq Age Sex Outcome Treatment
    1