BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VCL+ VIO 8X18IN 0 S/A CT-1 CR

    MDR report key: 23923719 · Received December 30, 2025

    Report

    Report Number
    2210968-2025-14667
    Event Type
    Malfunction
    Date Received
    December 30, 2025
    Date of Event
    November 12, 2025
    Report Date
    December 30, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031055193
    PMA / PMN Number
    K032420
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803, PART 4 SUBPART B. 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. 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 THIS EVENT CONTRIBUTE TO ANY PATIENT ADVERSE EVENT? IF YES, PLEASE EXPLAIN. - PLEASE PROVIDE THE LOT NUMBER. , LOT NUMBER SHOULD BE 102248.

    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, SUTURE WAS USED FOR SURGICAL SUTURING OF THE PATIENT. THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED, AND THE SURGERY CONTINUED AFTER REPLACING THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2196831 VCL+ VIO 8X18IN 0 S/A CT-1 CR SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. 102248 10705031055193

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown