BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VCL CT BRD UD 18IN 5-0 S/A P-3 PRM MP

    MDR report key: 18004250 · Received October 25, 2023

    Report

    Report Number
    2210968-2023-08154
    Event Type
    Malfunction
    Date Received
    October 25, 2023
    Date of Event
    January 1, 2023
    Report Date
    November 28, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031040496
    PMA / PMN Number
    K022269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. 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: MY COMPLAINT WAS 5.0 VICRYL, CLAIM NUMBER (B)(4). THE DOCTOR IS DR. (B)(6), NOT BOSTON CHILDREN HEALTH PHYSICIANS. I SPOKE WITH AGENT ID 702368962 FC. INTAKE WARRANTY COORDINATOR. JOHNSON AND JOHNSON, MED TECH., MENTOR. I AM NOT SURE WHERE THESE OTHER CLAIM NUMBERS COME FROM. PLEASE INFORM ME OF THE NEXT STEP IS TO SOLVE THIS ISSUE. 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 PRODUCT CODE FOR VICRYL 5.0 - LOT NUMBER - PROCEDURE NAME AND DATE - PLEASE PROVIDE THE PRODUCT CODE: - DO YOU HAVE ANY PHOTOS AVAILABLE FOR VISUAL ANALYSIS? - PLEASE PROVIDE THE SOURCE OR NAME OF PERSON PROVIDING ANSWERS TO FOLLOW-UP QUESTIONS:

    Additional Manufacturer Narrative · 0

    (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 REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED, AND NO RELATED NON-CONFORMANCES WERE IDENTIFIED. (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. CORRECTED INFORMATION: H6 TYPE OF INVESTIGATION (B17- DEVICE NOT RETURNED).

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 11/21/2023 THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED: ACCOUNT (B)(6), MD. PRODUCT CODE J493G. PRODUCT FUNCTIONAL FAMILY VICRYL ETHICON. SERIAL NUMBER: (B)(6). PROCEDURE MINI FACELIFT/UPPER BILATERAL BLEPHAROPLASTY. DATE UNKNOWN. PLEASE LET ME KNOW IF YOU NEED FURTHER INFORMATION. NOTE BODY (LOCAL LANGUAGE). 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE ACCOUNT CONTACT THAT SUTURE SEPARATION FROM THE NEEDLE FROM THE THREAD. IT HAPPENS WHEN THE NEEDLE IS GOING THROUGH THE HUB. IT HAS HAPPENED ABOUT 3 OR 4 TIMES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1047650 VCL CT BRD UD 18IN 5-0 S/A P-3 PRM MP SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. TAMCAK 10705031040496

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown