BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VICRYL RAP UND M3 USP2-0 90CM SA.V34

    MDR report key: 22700640 · Received August 4, 2025

    Report

    Report Number
    2210968-2025-08988
    Event Type
    Malfunction
    Date Received
    August 4, 2025
    Date of Event
    May 5, 2025
    Report Date
    August 4, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031119925
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # ==> (B)(4). H6 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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: - DID THE REPORTED ISSUE CONTRIBUTE TO ANY PATIENT ADVERSE CONSEQUENCES? NO, NONE LOT AV9840 WAS IMPACTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, START SUTURE OF A POST-DELIVERY TEAR BY OVERJET 1 THREAD 1 KNOT WITH DEVICE 1, THEN NEEDLE PULLED OFF FROM THE THREAD DURING THE PROCEDURE. END OF SUTURE OF THE CUTANEOUS PLANE WITH 4 SIMPLE STITCHES WITH DEVICE 2. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205705 VICRYL RAP UND M3 USP2-0 90CM SA.V34 SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. AV9840 10705031119925

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown