BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 18929021 · Received March 19, 2024

    Report

    Report Number
    2210968-2024-03164
    Event Type
    Injury
    Date Received
    March 19, 2024
    Report Date
    March 19, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. 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.

    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 OF ENDOSUTURE SYSTEM MADE WITH ETHIBOND EXCEL SUTURE. POSTPROCEDURAL BLEEDING AT INDEX ADMISSION: 9 PATIENTS, PRESENCE OF A DIAGNOSIS CODE FOR POSTPROCEDURAL HEMORRHAGE OR POSTPROCEDURAL HEMATOMA AS A PRIMARY OR SECONDARY DIAGNOSIS. SOURCE ICD-9/10-CM. WOUND DISRUPTION WITHIN 90 DAYS POST-INDEX PROCEDURE: 5 PATIENTS, PRESENCE OF A DIAGNOSIS CODE FOR WOUND DISRUPTION DURING THE INDEX ADMISSION OR DURING A RE-ADMISSION WITHIN 90 DAYS POST-INDEX PROCEDURE. SOURCE ICD-9/10-CM. SURGICAL SITE INFECTION WITHIN 90 DAYS POST-INDEX PROCEDURE: 19 PATIENTS, PRESENCE OF A DIAGNOSIS CODE FOR SURGICAL SITE INFECTION DURING THE INDEX ADMISSION OR DURING A READMISSION WITHIN 90 DAYS POST-INDEX PROCEDURE. SOURCE ICD-9/10-CM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2324542 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other