BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH

    MDR report key: 25303446 · Received May 27, 2026

    Report

    Report Number
    2210968-2026-05830
    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, LAPAROSCOPIC PROCEDURES AND 1-YEAR FOLLOW-UP). INTRAOPERATIVE COMPLICATIONS - TOTAL YES 30 1.3 2 2.0/ NO 2279 98.7 98 98.0. - BLEEDING: YES 26 1.1 1 1.0/ NO 2283 98.9 99 99.0. - ORGAN INJURIES: YES 19 0.8 2 2.0/ NO 2290 99.2 98 98.0. - - VASCULAR: YES 14 0.6 1 1.0/ NO 2295 99.4 99 99.0. - - BOWEL: YES 3 0.1 1 1.0/ NO 2306 99.9 99 99.0. - - BLADDER: YES 0 0 0 0/ NO 2309 100 100 100. - - NERVE (INGUINAL) YES 0 0 0 0/ NO 2309 100 100 100. - - OTHERS: YES 4 0.2 0 0/ NO 2305 99.8 100 100. GENERAL COMPLICATIONS - TOTAL YES 19 0.8 1 1.0/ NO 2290 99.2 99 99.0. - FEVER: YES 4 0.2 0 0/ NO 2305 99.8 100 100. - URINARY TRACT INFECTION: YES 2 <0.1 0 0/ NO 2307 >99.9 100 100. - DIARRHEA: YES 0 0 0 0/ NO 2309 100 100 100. - GASTRITIS: YES 0 0 0 0/ NO 2309 100 100 100. - THROMBOSIS: YES 1 <0.1 0 0/ NO 2308 >99.9 100 100. - PULMONARY EMBOLISM: YES 0 0 0 0/ NO 2309 100 100 100. - PLEURAL EFFUSION: YES 1 <0.1 0 0/ NO 2308 >99.9 100 100. - PNEUMONIA: YES 0 0 1 1.0/ NO 2309 100 99 99.0. - COPD: YES 0 0 0 0/ NO 2309 100 100 100. - CARDIAC INSUFFICIENCY YES 0 0 0 0 NO 2309 100 100 100 - CORONARY HEART DISEASE: YES 0 0 0 0/ NO 2309 100 100 100. - MYOCARDIAL INFARCTION YES 1 <0.1 0 0/ NO 2308 >99.9 100 100 - RENAL INSUFFICIENCY: YES 1 <0.1 0 0 NO 2308 >99.9 100 100. - HYPERTENSIVE CRISIS: YES 0 0 0 0/ NO 2309 100 100 100. - PATIENT DECEASED: YES 0 0 0 0 NO 2309 100 100 100 - OTHERS: YES 12 0.5 0 0/ NO 2297 99.5 100 100. POSTOPERATIVE COMPLICATIONS: - TOTAL YES 39 1.7 1 1.0/ NO 2270 98.3 99 99.0. - BLEEDING: YES 30 1.3 1 1.0/ NO 2279 98.7 99 99.0. - SEROMA: YES 5 0.2 0 0/ NO 2304 99.8 100 100. - PROLONGED ILEUS OR OBSTRUCTION: YES 2 <0.1 0 0/ NO 2307 >99.9 100 100. - BOWEL INJURY / ANASTOMOTIC INSUFFICIENCY: YES 1 <0.1 0 0/ NO 2308 >99.9 100 100/ - WOUND HEALING DISORDER: YES 4 0.2 0 0/ NO 2305 99.8 100 100. - INFECTION: YES 2 <0.1 0 0/ NO 2307 >99.9 100 100. COMPLICATION-RELATED REOPERATIONS: YES 13 0.6 0 0/ NO 2296 99.4 100 100. RECURRENCE, PAIN AND COMPLICATIONS ON 1-YEAR FOLLOW-UP: RECURRENCE ON 1-YEAR FOLLOW-UP: YES 16 0.7 0 0/ NO 2293 99.3 100 100. PAIN ON EXERTION ON 1-YEAR FOLLOW-UP: YES 175 7.6 11 11.0/ NO 2134 92.4 89 89.0. PAIN AT REST ON 1-YEAR FOLLOW-UP: YES 98 4.2 6 6.0/ NO 2211 95.8 94 94.0. PAIN REQUIRING TREATMENT ON 1-YEAR FOLLOW-UP: YES 60 2.6 0 0/ NO 2249 97.4 100 100. TROCAR HERNIA ON 1-YEAR FOLLOW-UP: YES 2 <0.1 0 0/ NO 2307 >99.9 100 100. SECONDARY HEMORRHAGE ON 1-YEAR FOLLOW-UP: YES 35 1.5 1 1.0/ NO 2274 98.5 99 99.0. SEROMA ON 1-YEAR FOLLOW-UP: YES 38 1.6 1 1.0/ NO 2271 98.4 99 99.0. INFECTION ON 1-YEAR FOLLOW-UP: YES 16 0.7 0 0/ NO 2293 99.3 100 100.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389940 PROLENE POLYPROPYLENE MESH MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other