BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VCL+ VIO 36IN 2-0 S/A CT

    MDR report key: 15336710 · Received September 1, 2022

    Report

    Report Number
    2210968-2022-07211
    Event Type
    Malfunction
    Date Received
    September 1, 2022
    Report Date
    September 20, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031052697
    PMA / PMN Number
    K132580
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS IS A COMBINATION PRODUCT, AND THE EVENT HAS BEEN REVIEWED FOR BOTH THE SUTURE AND THE TRICLOSAN. 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. 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. - PLEASE PROVIDE THE LOT NUMBER: - DEVICE RETURN STATUS: - WAS ANOTHER SUTURE USED TO SUCCESSFULLY COMPLETE THE SURGERY? TRADE NAME - IRGACARE®. ACTIVE INGREDIENT(S) ¿ TRICLOSAN. DOSAGE FORM ¿ SUTURE/SOLID/PARENTERAL. STRENGTH ¿ = 275 G/M. EVENTS REPORTED VIA 2210968-2022-07199, 2210968-2022-071200, 2210968-2022-071201, 2210968-2022-071202, 2210968-2022-071203, 2210968-2022-071204, 2210968-2022-071205, 2210968-2022-071206, 2210968-2022-071207, 2210968-2022-071208, 2210968-2022-071209, 2210968-2022-071210.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT#: (B)(4). DATE SENT TO THE FDA: 09/09/2022. 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. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: "PLEASE PROVIDE THE LOT NUMBER: NO FURTHER INFORMATION IS AVAILABLE. DEVICE RETURN STATUS: WE REGULARLY CONTACT WITH SALES REP ABOUT THE DEVICE RETURNING. NO FURTHER INFORMATION WILL BE PROVIDED."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND THE SUTURE WAS USED. DURING SURGERY, THE SUTURE BROKE DURING USE. ANOTHER LIKE DEVICE WAS USED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2822482 VCL+ VIO 36IN 2-0 S/A CT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. VCP357H 10705031052697

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown