BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE HERNIA SYSTEM MESH UNKNOWN PRODUCT

    MDR report key: 16582542 · Received March 21, 2023

    Report

    Report Number
    2210968-2023-01852
    Event Type
    Injury
    Date Received
    March 21, 2023
    Date of Event
    October 19, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K984220
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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 JOURNAL ARTICLE; 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. CLINICAL CODE: E2402 ¿ FOREIGN BODY SENSATION. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. RELATED EVENTS CAPTURED VIA 2210968-2023-01851. CITATION: JMIR FORM RES 2022, VOL. 6, ISS. 10, E39759, P. 1; DOI: 10.2196/39759.

    Description of Event or Problem · 0

    TITLE: LONG-TERM FOLLOW-UP OF PATIENTS WITH HERNIA USING THE HERNIA-SPECIFIC QUALITY-OF-LIFE MOBILE APP: FEASIBILITY QUESTIONNAIRE STUDY. THE AIM OF THIS STUDY WAS TO EXAMINE THE USE OF A MOBILE APP FOR THE LONG-TERM FOLLOW-UP OF HERNIA RECURRENCE, COMPLICATION, AND QUALITY-OF-LIFE PERCEPTION. BETWEEN APRIL 1, 2016, AND MARCH 31, 2017, 2615 PATIENTS WHO HAD THEIR HERNIA REPAIRED WERE INVITED TO PARTICIPATE IN THE STUDY. AMONG THEM, 2245 WERE MALE AND 370 WERE FEMALE. THE MEAN AGE WAS 60 (SD 15) YEARS (MEDIAN 62; RANGE 18-95 YEARS). THERE WERE 311 PATIENTS WHO FOLLOWED THE INSTRUCTIONS, WITH SUCCESSFUL LOG-ON, AND COMPLETED THE HERQL SURVEY. THERE WERE 93 ABDOMINAL WALL (IE, INCISIONAL AND VENTRAL) HERNIAS, 202GROIN HERNIAS, AND 16 PATIENTS HAD BOTH. THE EARLIEST HERNIA REPAIR TOOK PLACE MORE THAN 13 YEARS AGO (MEAN 5.5, SD2.7 YEARS; MEDIAN 5.4, RANGE 1-13.6 YEARS). MOST RESPONDERS WERE WITHIN 5 YEARS OF HERNIA REPAIRS. PROLENE HERNIA SYSTEM (ETHICON) OR ULTRAPRO HERNIA SYSTEM (ETHICON) WERE USED TO TREAT 57 PATIENTS WITH GROIN HERNIA AND 11 PATIENTS WITH ABDOMINAL HERNIA. THE REST OF THE PATIENTS WERE TREATED WITH COMPETITORS MESH (BRANDS: COMPOSIX OR VENTRIO, KUGEL OR MODIFIED KUGEL, PARIETEX, MESH PLUG), LAPARASCOPY, AND OTHERS. THE REPORTED COMPLICATIONS INCLUDED PAIN (N=?), FOREIGN BODY SENSATION (N=?), DISCOMFORT (N=?), COMPROMISED FUNCTIONALITY (N=?), AND HERNIA RECURRENCE (N=1). IN CONCLUSION, THE MOBILE APP HAS THE POTENTIAL TO ENHANCE THE QUALITY OF CARE FOR PATIENTS WITH HERNIA AND FACILITATE OUTCOMES RESEARCH WITH MORE COMPLETE FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18144 PROLENE HERNIA SYSTEM MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention