BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE HERNIA SYSTEM UNKNOWN PRODUCT

    MDR report key: 24552522 · Received March 9, 2026

    Report

    Report Number
    2210968-2026-02419
    Event Type
    Injury
    Date Received
    March 9, 2026
    Report Date
    March 9, 2026
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K984220
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. 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 PROLENE HERNIA SYSTEM. ICD-10-CM DIAGNOSIS AND CPT PROCEDURE CODES: HERNIA RECURRENCE PRESENCE OF ICD-10-CM DIAGNOSIS CODE (PRIMARY OR SECONDARY) FOR RECURRENCE FOR GROIN HERNIAS, OR A PRIMARY DIAGNOSIS CODE FOR A FOLLOW-UP DIAGNOSIS FOR NON-GROIN PRIMARY OR INCISIONAL HERNIAS, OR A CPT CODE (SEE APPENDIX 1) WITHIN 36 MONTHS POST-DISCHARGE FROM THE INDEX EPISODE OF CARE. OPEN GROIN: 143 , LAPAROSCOPIC GROIN: 3 , OPEN NON-GROIN PRIMARY: 4 , LAPAROSCOPIC NON-GROIN , PRIMARY: 1 , OPEN INCISIONAL: 6. ICD-10-CM DIAGNOSIS CODES: POSTPROCEDURAL INFECTION PRESENCE OF AN ICD-10-CM DIAGNOSIS CODE (PRIMARY OR SECONDARY) FOR POSTPROCEDURAL INFECTION (SEE APPENDIX 2) WITHIN 90 DAYS POST-INDEX PROCEDURE. OPEN GROIN: 81, LAPAROSCOPIC GROIN: 2 , OPEN NON-GROIN PRIMARY: 3 , OPEN INCISIONAL: 2 . ICD-10-CM DIAGNOSIS CODES: POSTPROCEDURAL SEROMA PRESENCE OF AN ICD-10-CM DIAGNOSIS CODE (PRIMARY OR SECONDARY) FOR POSTPROCEDURAL SEROMA (SEE APPENDIX 3) WITHIN 90 DAYS POST-INDEX PROCEDURE. OPEN GROIN: 17 , OPEN INCISIONAL:1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605106 PROLENE HERNIA SYSTEM UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention