BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOKNOT PRE-TIED SUTURE UNKNOWN PRODUCT

    MDR report key: 18256265 · Received December 4, 2023

    Report

    Report Number
    2210968-2023-09411
    Event Type
    Injury
    Date Received
    December 4, 2023
    Report Date
    December 4, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    MPN
    PMA / PMN Number
    K925914
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    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. THIS REPORT IS RELATED TO A CLINICAL EVALUATION REPORT; 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. NOTE: RELATED EVENTS REPORTED VIA 2210968-2023-09410.

    Description of Event or Problem · 0

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A RELATED RESEARCH ACTIVITY DATABASE (DRRA) FOR PATIENTS UNDERGOING UNKNOWN PROCEDURE. THE REPORTED COMPLICATION AS PER ICD 9 & 10 CATEGORIZATION EXPERIENCED BY THE FOLLOWING WITH CORRESPONDING INTERVENTION: EVALUATION OF PERFORMANCE AND SAFETY OUTCOMES FOR ENDOKNOT¿ SUTURES MADE WITH COATED VICRY SUTURE AND PDS II (POLYDIOXANONE) SUTURE. POSTPROCEDURAL BLEEDING: ENDOKNOT VICRYL: 0, ENDOKNOT PDS II: 0 TOTAL PATIENTS 0, PRESENCE OF DIAGNOSIS CODE INDICATING POSTPROCEDURAL HEMORRHAGE OR POSTPROCEDURAL HEMATOMA DURING THE INDEX ADMISSION WHERE A STUDY DEVICE WAS USED, DIAGNOSIS CODE ICD-10-CM. SURGICAL SITE INFECTION: ENDOKNOT VICRYL: 1, ENDOKNOT PDS II: 0 TOTAL PATIENTS 1, PRESENCE OF DIAGNOSIS CODE INDICATING SURGICAL SITE INFECTION DURING THE INDEX ADMISSION WHERE A STUDY DEVICE WAS USED, DIAGNOSIS CODE ICD-10-CM. WOUND DISRUPTION: ENDOKNOT VICRYL: 0, ENDOKNOT PDS II: 2 TOTAL PATIENTS 2, PRESENCE OF DIAGNOSIS CODE INDICATING WOUND DISRUPTION DURING, THE INDEX WHERE A STUDY DEVICE WAS USED, DIAGNOSIS CODE ICD-10-CM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1399783 ENDOKNOT PRE-TIED SUTURE UNKNOWN PRODUCT ADHESIVE, TOPICAL SKIN MPN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other