BEUDAMED
    FDA Adverse Event Injury Summary report: N

    J-VAC RESERVOIR UNKNOWN PRODUCT

    MDR report key: 16284521 · Received February 2, 2023

    Report

    Report Number
    2210968-2023-00750
    Event Type
    Injury
    Date Received
    February 2, 2023
    Report Date
    February 2, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    JOL
    PMA / PMN Number
    CL II EXEMPT
    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 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. COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. RELATED EVENTS CAPTURED VIA MW#: 2210968-2023-00751. 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

    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: UTILIZATION AND COMPARATIVE ANALYSIS OF CLOSED WOUND DRAINAGE SYSTEM. 697 TOTAL PATIENTS, DEFINED AS THE PRESENCE OF AN ICD-9/10-CM DIAGNOSIS CODES FOR HEMATOMA AND/OR SEROMA POST-PROCEDURE COMPLICATION AFTER THE PROCEDURE WITH USE OF THE DEVICE AND BEFORE THE DISCHARGE OF THE INDEX ADMISSION WAS DEFINED USING DIAGNOSIS CODES. 699 TOTAL PATIENTS, DEFINED AS THE PRESENCE OF AN ICD-9/10-CM DIAGNOSIS CODE FOR SURGICAL SITE INFECTION POST-PROCEDURE COMPLICATION AFTER THE PROCEDURE WITH USE OF THE DEVICE AND BEFORE THE DISCHARGE OF THE INDEX HOSPITALIZATION WAS DEFINED USING DIAGNOSIS CODES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    955067 J-VAC RESERVOIR UNKNOWN PRODUCT CATHETER AND TIP SUCTION JOL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other