BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VCL+ VIO 8X18IN 2-0 S/A CT-2 CR

    MDR report key: 15288476 · Received August 24, 2022

    Report

    Report Number
    2210968-2022-06900
    Event Type
    Malfunction
    Date Received
    August 24, 2022
    Report Date
    October 5, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031055117
    PMA / PMN Number
    K032420
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT NUMBER: (B)(4).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. MRE NOT COMPLETED AT TIME OF INITIAL MEDWATCH REPORT ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: *ARE THERE ANY PHOTOS OF THE PACKAGE AVAILABLE?WE WILL ATTACH THE PHOTO ON THE ECM. * DID THE OUTER PACKAGE SHOW ANY SIGNS OF DAMAGED WHEN RECEIVED?NO. WE JUST HAVE THE PHOTO AND THERE IS NO DAMAGE ON THE PACKAGE. * WAS THE PACKAGE PROPERLY SEALED WHEN RECEIVED?WE DO NOT HAVE THE PACKAGE NOW. * PLEASE PROVIDE THE LOT NUMBER:NO FURTHER INFORMATION IS AVAILABLE *PLEASE PROVIDE DETAILS OF THE INITIAL REPORTER (EMAIL):NO FURTHER INFORMATION IS AVAILABLE. NO FURTHER INFORMATION WILL BE PROVIDED." LOT NUMBER : UNK :RP2ACU 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 THIS IS A COMBINATION PRODUCT, AND THE EVENT HAS BEEN REVIEWED FOR BOTH THE SUTURE AND THE TRICLOSAN. TRADE NAME - IRGACARE. ACTIVE INGREDIENT(S)- TRICLOSAN. DOSAGE FORM - SUTURE/SOLID/PARENTERAL. STRENGTH -= 275 G /M.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #(B)(4). DATE SENT TO THE FDA: 10/5/2022. 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. H6 COMPONENT CODE: G07002 NO DEVICE RETURNED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. H3 INVESTIGATIONAL SUMMARY ¿ PHOTO ANALYSIS: THIS IS AN ANALYSIS OF A PHOTO SUBMITTED TO ETHICON FOR EVALUATION. DURING THE VISUAL ANALYSIS THE FOLLOWING WAS OBSERVED: THE PHOTOGRAPH SHOWS AN ALUMINUM PACKAGE WAS OBSERVED, PRODUCT CODE VCP726D, LOT NUMBER RP2AC, NO LABELING ISSUES WERE FOUND ON THE PRODUCT. THE FINISHED DRAWING WAS COMPARED WITH THE RECEIVED IMAGE AND ALL INFORMATION WAS CORRECT. AS PART OF ETHICON'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING OF COMPLAINT INFORMATION FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDS AS PART OF POST-MARKET SURVEILLANCE. TRADE NAME - IRGACARE. ACTIVE INGREDIENT(S)- TRICLOSAN. DOSAGE FORM - SUTURE/SOLID/PARENTERAL. STRENGTH -= 275 G /M.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN OB-GYN SURGERY, ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE IT WAS NOTED THE NEEDLE SIZE INDICATED ON THE PACKAGE SHOULD USUALLY BE WRITTEN AS 26 MM, BUT IT WAS WRITTEN AS 27 MM. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2164146 VCL+ VIO 8X18IN 2-0 S/A CT-2 CR SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. VCP726D RP2ACU 10705031055117

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown