BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH

    MDR report key: 25303439 · Received May 27, 2026

    Report

    Report Number
    2210968-2026-05832
    Event Type
    Injury
    Date Received
    May 27, 2026
    Date of Event
    January 1, 2026
    Report Date
    May 27, 2026
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Removal / Correction Number
    N/A
    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 COMPLAINT WAS IDENTIFIED THROUGH THE CLINICAL EVALUATION REPORT (CER) PROCESS. THE CER PROCESS IS CONDUCTING A RETROSPECTIVE LITERATURE REVIEW FOR THE LIFE OF THE PRODUCT AND IN SOME CASES IDENTIFYING COMPLAINTS IN ARTICLES THAT CANNOT BE REASONABLY INVESTIGATED DUE TO THE AGE OF THE ARTICLE. ADDITIONALLY, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. 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: HERNIAMED REGISTRY EXTRACTION ETHICON PROLENE MESH & PROLENE SOFT MESH: (ELECTIVE UNILATERAL INGUINAL HERNIA REPAIR, OPEN PROCEDURES AND 1-YEAR FOLLOW-UP) INTRAOPERATIVE COMPLICATIONS INTRAOPERATIVE COMPLICATIONS - TOTAL YES 19 1.1 0 0, NO 1715 98.9 87 100, BLEEDING YES 9 0.5 0 0, NO 1725 99.5 87 100, ORGAN INJURIES YES 13 0.7 0 0, NO 1721 99.3 87 100, VASCULAR YES 3 0.2 0 0, NO 1731 99.8 87 100, BOWEL YES 1 <0.1 0 0, NO 1733 >99.9 87 100, BLADDER YES 2 0.1 0 0, NO 1732 99.9 87 100, NERVE (INGUINAL) YES 2 0.1 0 0, NO 1732 99.9 87 100, OTHERS, YES 5 0.3 0 0, NO 1729 99.7 87 100. GENERAL COMPLICATIONS: GENERAL COMPLICATIONS - TOTAL YES 22 1.3 1 1.1, NO 1712 98.7 86 98.9, FEVER YES 2 0.1 0 0, NO 1732 99.9 87 100, URINARY TRACT INFECTION YES 1 <0.1 0 0, NO 1733 >99.9 87 100, DIARRHEA YES 1 <0.1 0 0, NO 1733 >99.9 87 100, GASTRITIS YES 1 <0.1 0 0, NO 1733 >99.9 87 100, THROMBOSIS YES 0 0 0 0, NO 1734 100 87 100, PULMONARY EMBOLISM YES 0 0 0 0, NO 1734 100 87 100, PLEURAL EFFUSION YES 0 0 0 0, NO 1734 100 87 100, PNEUMONIA YES 1 <0.1 0 0, NO 1733 >99.9 87 100, COPD YES 0 0 0 0, NO 1734 100 87 100, CARDIAC INSUFFICIENCY YES 0 0 0 0, NO 1734 100 87 100, CORONARY HEART DISEASE YES 0 0 1 1.1, NO 1734 100 86 98.9, MYOCARDIAL INFARCTION YES 1 <0.1 0 0, NO 1733 >99.9 87 100, RENAL INSUFFICIENCY YES 0 0 1 1.1, NO 1734 100 86 98.9, HYPERTENSIVE CRISIS YES 0 0 0 0, NO 1734 100 87 100, PATIENT DECEASED YES 0 0 0 0, NO 1734 100 87 100, OTHERS YES 16 0.9 0 0, NO 1718 99.1 87 100. POSTOPERATIVE COMPLICATIONS: POSTOPERATIVE COMPLICATIONS - TOTAL YES 73 4.2 6 6.9, NO 1661 95.8 81 93.1, BLEEDING YES 46 2.7 3 3.4, NO 1688 97.3 84 96.6, SEROMA YES 25 1.4 3 3.4, NO 1709 98.6 84 96.6, PROLONGED ILEUS OR OBSTRUCTION YES 0 0 0 0, NO 1734 100 87 100, BOWEL INJURY / ANASTOMOTIC INSUFFICIENCY YES 1 <0.1 0 0, NO 1733 >99.9 87 100, WOUND HEALING DISORDER YES 3 0.2 0 0, NO 1731 99.8 87 100, INFECTION YES 2 0.1 0 0, NO 1732 99.9 87 100. COMPLICATION-RELATED REOPERATIONS. COMPLICATION-RELATED REOPERATIONS: YES 18 1.0 2.3 2, NO 1716 99.0 85 97.7. RECURRENCE, PAIN AND COMPLICATIONS ON 1-YEAR FOLLOW-UP: RECURRENCE ON 1-YEAR FOLLOW-UP YES 20 1.2 1 1.1, NO 1714 98.8 86 98.9, PAIN ON EXERTION ON 1-YEAR FOLLOW-UP YES 176 10.1 9 10.3, NO 1558 89.9 78 89.7, PAIN AT REST ON 1-YEAR FOLLOW-UP YES 90 5.2 7 8.0, NO 1644 94.8 80 92.0, PAIN REQUIRING TREATMENT ON 1-YEAR FOLLOW-UP YES 49 2.8 5 5.7, NO 1685 97.2 82 94.3, TROCAR HERNIA ON 1-YEAR FOLLOW-UP YES 0 0 0 0, NO 1734 100 87 100, SECONDARY HEMORRHAGE ON 1-YEAR FOLLOW-UP YES 32 1.8 0 0, NO 1702 98.2 87 100, SEROMA ON 1-YEAR FOLLOW-UP YES 41 2.4 2 2.3, NO 1693 97.6 85 97.7. INFECTION ON 1-YEAR FOLLOW-UP: YES 21 1.2 0 0, NO 1713 98.8 87 100.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344184 PROLENE POLYPROPYLENE MESH MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other