BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STLESS STEEL SIL 4X18IN 5 S/A V-40

    MDR report key: 21871987 · Received April 21, 2025

    Report

    Report Number
    2210968-2025-04205
    Event Type
    Malfunction
    Date Received
    April 21, 2025
    Date of Event
    February 24, 2025
    Report Date
    April 18, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAQ
    UDI-DI
    10705031045439
    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). 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. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: WHEN DID THE NEEDLES DETACH OR PULL OFF FROM THE SUTURE THREAD (REMOVAL FROM PACKAGE / DURING HANDLING PRIOR TO USE ON PATIENT/ DURING PASSAGE THROUGH TISSUE / DURING TYING / POST-OP)? DURING PASSAGE THROUGH TISSUE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 100M3K / M650G19 BATCH NUMBER, AND NO 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, 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 AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE HAPPENED IN SURGERY. CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY, AND THE SAME PROBLEM HAPPENED AGAIN. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1352933 STLESS STEEL SIL 4X18IN 5 S/A V-40 SUTURE, NONABSORBABLE, STEEL GAQ ETHICON INC. 100M3K 10705031045439

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown