BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCEED MESH

    MDR report key: 24430533 · Received February 24, 2026

    Report

    Report Number
    2210968-2026-01923
    Event Type
    Injury
    Date Received
    February 24, 2026
    Date of Event
    January 1, 2026
    Report Date
    February 24, 2026
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K060713
    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 THE PERFORMANCE AND SAFETY OF PROCEED SURGICAL MESH. ICD 9 DIAGNOSIS; ICD 10 DIAGNOSIS; CPT CODE HERNIA RECURRENCE PRESENCE OF AN ICD-9-CM OR ICD-10-CM DIAGNOSIS CODE FOR A POST-INDEX DIAGNOSIS OF HERNIA (PRIMARY OR SECONDARY DIAGNOSIS CODE FOR RECURRENCE FOR GROIN HERNIAS OR A PRIMARY DIAGNOSIS CODE FOR A FOLLOW-UP DIAGNOSIS OF NON-GROIN PRIMARY OR INCISIONAL HERNIA) OR A CPT CODE (APPENDIX 3 TABLE 3) WITHIN 36 MONTHS FOLLOWING DISCHARGE FROM THE INDEX EPISODE OF CARE 644. ICD 9 DIAGNOSIS. ICD 10 DIAGNOSIS INFECTION PRESENCE OF AN ICD-9-CM OR ICD-10-CM DIAGNOSIS CODE (PRIMARY OR SECONDARY) FOR INFECTION (APPENDIX 3 TABLE 4) WITHIN 100 DAYS FOLLOWING THE INDEX PROCEDURE 94 . ICD 9 DIAGNOSIS. ICD 10 DIAGNOSIS SEROMA. PRESENCE OF AN ICD-9-CM OR ICD-10-CM DIAGNOSIS CODE (PRIMARY OR SECONDARY) FOR POST-PROCEDURAL SEROMA (APPENDIX 3 TABLE 5). WITHIN 100 DAYS FOLLOWING THE INDEX PROCEDURE 163.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487108 PROCEED MESH MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other