BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STLESS STEEL SIL 4X18IN 7 S/A CPX

    MDR report key: 21899389 · Received April 24, 2025

    Report

    Report Number
    2210968-2025-04465
    Event Type
    Malfunction
    Date Received
    April 24, 2025
    Date of Event
    March 27, 2025
    Report Date
    April 24, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAQ
    UDI-DI
    10705031125278
    PMA / PMN Number
    K946173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4). DATE SENT TO THE FDA: 4/24/2025. 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, 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(4) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE DETACHES FROM THE WIRE WITHOUT APPLYING FORCE. IT OCCURRED 3 TIMES. TO PROCEDURE COMPLETED PHYSICIAN USED ANOTHER ONE PRODUCT THE SAME TYPE. NO CONSEQUENCES FOR THE PATIENT REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476489 STLESS STEEL SIL 4X18IN 7 S/A CPX SUTURE, NONABSORBABLE, STEEL GAQ ETHICON INC. SMBASJ 10705031125278

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown