BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCRYL VIO 36IN 3-0 S/A FS-2

    MDR report key: 17143512 · Received June 16, 2023

    Report

    Report Number
    2210968-2023-04369
    Event Type
    Malfunction
    Date Received
    June 16, 2023
    Date of Event
    January 1, 2023
    Report Date
    July 25, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    UDI-DI
    10705031059863
    PMA / PMN Number
    K960653
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. ADDITIONAL INFORMATION: D4, G1, H4 CORRECTED H6 - TYPE OF INVESTIGATION.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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 BATCH, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    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. 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: THIS EMAIL IS IN RESPONSE TO YOUR REQUEST FOR ADDITIONAL INFORMATION. YOU HAVE LISTED IN YOUR REQUEST PROCEDURES 1-4. THE FIRST RETURN WAS A CAT THAT RETURNED THE DAY AFTER SURGERY HAD A HERNIA IN THE ABDOMINAL WALL. THIS HERNIA WAS REPAIRED AND THE CAT SENT HOME. THE CAT THE NEXT DAY RETURNED TO THE CLINIC WITH A HERNIA IN THE ABDOMINAL WALL. THIS TIME THE DOCTOR USED A DIFFERENT SUTURE TO REPAIR THE HERNIA. THE CAT DID FINE. WE HAD A SECOND CAT COME IN WITH A HERNIA IN THE ABDOMINAL WALL. WE REPAIRED THE HERNIA WITH A DIFFERENT SUTURE AND THE CAT DID FINE. WE HAD A DOG COME IN WITH A LACERATION AROUND HIS NECK. THE SAME SUTURE WAS USED ON THE CATS DURING THEIR ORIGINAL SURGERIES FOR THE LACERATION. THE DOG CAME BACK 2 DAYS AFTER THE REPAIR AND THE SUTURE HAD FAILED. WE REPAIRED THE LACERATION AGAIN WITH A DIFFERENT SUTURE AND THE DOG HEALED FINE. THIS IS ALL OF THE PROCEDURES THAT WE USED THE ETHICON AND THEY HAD ISSUES. PLEASE LET ME KNOW IF YOU NEED ANY MORE INFORMATION. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL PATIENT EVENTS. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. LEASE PROVIDE AN ANSWER FOR EACH CASE: (B)(4) : FELINE 1. 1ST PROCEDURE. ISSUE: HERNIA. (B)(4) : FELINE 1. 2ND PROCEDURE. ISSUE: FELINE 1 RETURNED TO THE CLINIC WITH A HERNIA IN THE ABDOMINAL WALL. (B)(4) : FELINE 2. 3RD PROCEDURE. ISSUE: HERNIA. (B)(4): DOG 1. 4TH PROCEDURE. ISSUE: SUTURE HAS FAILED. WAS ANY QUALITY DEFICIENCY/NON-CONFORMANCE NOTED WITH THE SUTURE AFTER THE 2ND SURGERY IN FELINE 1? IT WAS REPORTED A DOG CAME BACK 2 DAYS AFTER THE REPAIR AND THE SUTURE HAD FAILED, HOW THE SUTURE FAILED? PLEASE PROVIDE THE LOT NUMBER FOR EACH PRODUCTS INVOLVED IN EACH PROCEDURE: PLEASE PROVIDE THE FOUR PROCEDURE DATES: DEVICE RETURN STATUS. PLEASE DOCUMENT THE SHIPMENT TRACKING NUMBER: PLEASE PROVIDE THE SOURCE OR NAME OF PERSON PROVIDING ANSWERS TO FOLLOW-UP QUESTIONS:

    Description of Event or Problem · 0

    IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE VETERINARY THAT THE FELINES OHES PREFORMED W/SAME BOX OF SUTURE CAME BACK WITH HERNIAS TWICE. ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE SUTURE HAD FAILED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452450 MCRYL VIO 36IN 3-0 S/A FS-2 SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC. Y923H TAMJPX 10705031059863

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown