BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE INTERCEED 5INX6IN

    MDR report key: 13261999 · Received January 14, 2022

    Report

    Report Number
    2210968-2022-00429
    Event Type
    Injury
    Date Received
    January 14, 2022
    Date of Event
    December 15, 2021
    Report Date
    January 14, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    MCN
    UDI-DI
    10705031147843
    PMA / PMN Number
    P880047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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 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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. EVENT RELATED TO INTERCEED DEVICE - 4350 REPORTED VIA MW # (B)(4). EVENT RELATED TO INTERCEED DEVICE - M4350 REPORTED VIA MW # (B)(4). EVENT RELATED TO INTERCEED DEVICE - M4345 REPORTED VIA MW # (B)(4). EVENT RELATED TO INTERCEED DEVICE - M4350N REPORTED VIA MW # (B)(4).

    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 A GYNECOLOGICAL PROCEDURE. THE REPORTED COMPLICATION AS PER ICD 9 & 10 CATEGORIZATION EXPERIENCED BY THE FOLLOWING WITH CORRESPONDING INTERVENTION: 3,359 GYNECOLOGIC (INTERCEED: 2,086; SEPRAFILM: 1,273) PATIENTS HAD PERI-OPERATIVE COMPLICATION AFTER THE PROCEDURE WITH THE USE OF THE DEVICE AND BEFORE THE DISCHARGE OF THE INDEX HOSPITALIZATION WERE DEFINED WITH THE DIAGNOSIS CODE, ADHESION-RELATED REOPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859549 GYNECARE INTERCEED 5INX6IN BARRIER, ABSORBABLE, ADHESION MCN ETHICON INC. 4350XL 10705031147843

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention