BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCRYL VIO 36IN 2-0 S/A SH MP

    MDR report key: 18502632 · Received January 12, 2024

    Report

    Report Number
    2210968-2024-00380
    Event Type
    Malfunction
    Date Received
    January 12, 2024
    Date of Event
    December 1, 2023
    Report Date
    January 12, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    UDI-DI
    10705031059528
    PMA / PMN Number
    K960653
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT(B)(4). DATE SENT TO THE FDA: 1/12/2024 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. ADDITIONAL INFORMATION PROVIDED: OVER THE WEEKEND THE OWNER NOTICED THE CAT LOOKED LIKE IT WAS RETAINING FLUID, SHE BROUGHT THE CAT IN TODAY, BOTH KNOTS WERE IN TACT, THEY OPENED THE CAT UP AND IT HAD BROKEN IN THE CAT. 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 AN ANIMAL UNDERWENT A SPAY OHE INCISION CLOSURE IN DECEMBER 2023. DURING THE PROCEDURE, THE SUTURE BROKE. THE SKIN SUTURE CLOSURE AND SWAGE INTACT. MUSCLE SUTURE CLOSURE BROKE IN MIDDLE, BOTH TIES ON EACH END WERE INTACT. UNKNOWN HOW THE CASE WAS COMPLETED. ABDOMINAL ORGANS HERNIATED THROUGH MUSCLE. SECOND SURGERY TO REPAIR HERNIA ONE HOUR DURATION. DEVICE IS NOT AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2003492 MCRYL VIO 36IN 2-0 S/A SH MP SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC. THMPQU 10705031059528

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR Female