BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON 60MM REINFORCEMENT

    MDR report key: 17965315 · Received October 19, 2023

    Report

    Report Number
    3005075853-2023-07665
    Event Type
    Injury
    Date Received
    October 19, 2023
    Date of Event
    January 1, 2023
    Report Date
    October 19, 2023
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    OXC
    UDI-DI
    10705036023296
    PMA / PMN Number
    K190937
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 10/19/2023, D4: BATCH # UNK, B3: EXACT EVENT DATE UNK, ENTERED 1/1/2023 AS NO EVENT DATE WAS PROVIDED. THIS REPORT IS RELATED TO A CLINICAL EVALUATION REPORT FROM A RELATED RESEARCH ACTIVITY DATABASE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE MANUFACTURING RECORDS CANNOT BE REVIEWED AS THE LOT/BATCH NUMBER HAS NOT BEEN PROVIDED. 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, 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.

    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: CLINICAL AND HEALTHCARE UTILIZATION OUTCOMES OF PATIENTS UNDERGOING GASTRIC SURGERY USING ECHELON ENDOPATHTM STAPLE-LINE REINFORCEMENT VS. OTHER STAPLE-LINE BUTTRESS MATERIAL WERE DEFINED WITH THE DIAGNOSIS CODE, HEMOSTASIS, POSTPROCEDURAL COMPLICATIONS AND DISORDERS OF DIGESTIVE SYSTEM, BLOOD TRANSFUSION, INPATIENT READMISSION, EMERGENCY DEPARTMENT VISIT, AND INTRA-ABDOMINAL ABSCESS, INTRA- AND POSTOPERATIVE INTERVENTIONS TO CONTROL BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97001 ECHELON 60MM REINFORCEMENT OXC OXC ETHICON ENDO-SURGERY, LLC. 10705036023296

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other