BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 19991858 · Received August 15, 2024

    Report

    Report Number
    2210968-2024-08557
    Event Type
    Injury
    Date Received
    August 15, 2024
    Date of Event
    July 1, 2023
    Report Date
    August 15, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    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. 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. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. CITATION: HTTPS://DOI.ORG/10.1161/CIRCEP.122.011447.

    Description of Event or Problem · 0

    TITLE: TRANSCATHETER LEADLESS PACING IN CHILDREN: A PACES COLLABORATIVE STUDY IN THE REAL-WORLD SETTING. THE OBJECTIVES OF THIS STUDY ARE TO EVALUATE CLINICAL INDICATIONS, PROCEDURAL CHARACTERISTICS, ELECTRICAL PERFORMANCE, AND OUTCOMES OF TLP IMPLANTATION IN CHILDREN. A RETROSPECTIVE STUDY WAS CONDUCTED IN PATIENTS =21 YEARS OF AGE WHO UNDERWENT TLP IMPLANTATION. IN CASES OF FEMORAL VENOUS ACCESS, HEMOSTASIS WAS ACHIEVED BY A VARIETY OF SURGICAL SUTURES (FIGURE OF 8, Z, OR PURSE STRING SUTURE) AT ACCESS SITE USING NONABSORBABLE MATERIAL (ETHIBOND; JOHNSON & JOHNSON INC, NEW BRUNSWICK, NJ; TICRON, MEDTRONIC INC, MINNEAPOLIS, MN; PROLENE, NEW BRUNSWICK, NJ; ETHICON. THE REPORTED COMPLICATIONS INCLUDED: - 7-YEAR-OLD, FEMALE, (N=1) PERICARDIAL EFFUSION WITH TAMPONADE, TREATMENT: SURGERY - (N=3) BLEEDING, TREATMENT: MANUAL COMPRESSION, -(N=1) HEMATOMA, TREATMENT: NOT MENTIONED. IN CONCLUSION, INITIAL RESULTS FROM THE PEDIATRIC AND CONGENITAL ELECTROPHYSIOLOGY SOCIETY TLP REGISTRY DEMONSTRATED A HIGH LEVEL OF SUCCESSFUL MICRA DEVICE IMPLANTS VIA FEMORAL AND INTERNAL VENOUS JUGULAR APPROACHES WITH STABLE ELECTRICAL PARAMETERS AND INFREQUENT MAJOR COMPLICATIONS. LONG-TERM PROSPECTIVE DATA ARE NEEDED TO CONFIRM THE REPRODUCIBILITY OF THESE INITIAL FINDINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1639864 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Female Required Intervention