BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PDSII VIO 36IN 0 S/A CT

    MDR report key: 21008532 · Received December 23, 2024

    Report

    Report Number
    2210968-2024-13930
    Event Type
    Malfunction
    Date Received
    December 23, 2024
    Date of Event
    January 1, 2024
    Report Date
    December 23, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    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. 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 AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE IN 2024 AND SUTURE WAS USED. POST-OP, IT WAS REPORTED BY HEALTHCARE PROFESSIONAL THAT THEY HAD A PATIENT IN FOR A PROCEDURE, 130# GREATDANE FOR OHE/ GASTROPEXY. THE DVM USED 0 PDS IN A CONTINUOUS PATTERN TO CLOSE HER LINEA ALBA. PATIENT HAD AN UNREMARKABLE RECOVERY POST SURGERY AND WAS RECOVERED IN A KENNEL. UPON RELEASE OF THE PATIENT, LARGE QUANTITIES OF FRANK BLOOD WERE NOTED FROM THE INCISION SITE. PATIENT WAS SENT TO THE LOCAL ER, WHERE A SECONDARY PROCEDURE WAS PERFORMED. ONE OF THE DVM'S OVERING SEEING THE TRANSFER, WAS INFORMED THAT THE SUTURE HAD BROKEN. THE SUTURE WOULD HAVE BROKEN OR TORN ONLY A FEW HOURS POST-OP, WITH VERY LIMITED MOVEMENT BY THE PATIENT. DEVICE AVAILABILITY UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2625582 PDSII VIO 36IN 0 S/A CT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC. TGMCDR

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown