BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERSILENE POLYESTER FIBER MESH

    MDR report key: 25186245 · Received May 15, 2026

    Report

    Report Number
    2210968-2026-05379
    Event Type
    Injury
    Date Received
    May 15, 2026
    Date of Event
    November 11, 2006
    Report Date
    May 15, 2026
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    PRE-AMEND
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IR
    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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? 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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. CITATION: HERNIA. 2007 FEB;11(1):25-9. HTTPS://DOI.ORG/10.1007/S10029-006-0141-Z EPUB 2006 NOV 11. PMID: 17102903.

    Description of Event or Problem · 0

    TITLE: OUTCOMES OF THE RIVES-STOPPA TECHNIQUE IN INCISIONAL HERNIA REPAIR: TEN YEARS OF EXPERIENCE. THE AIM OF THIS STUDY IS TO ASSESS THE OUTCOMES OF IRANIAN PATIENTS UNDERGOING THE R¿S TECHNIQUE AND TO DETERMINE FACTORS AFFECTING RECURRENCE RATE AND TIME. BETWEEN 1993 AND 2003, A TOTAL OF 86 PATIENTS WITH VENTRAL INCISIONAL HERNIA IN OUR STUDY GROUP, 20 (23%) WERE MALES AND 66(75.9%) WERE FEMALES;16.1% HAD ONE, 10.3% HAD TWO, AND 2.3% HAD THREE PRIOR HERNIA REPAIRS. MEAN AGE OF 51.21 (30¿91). TWO TYPES OF MESH WERE USED, PROLENE AND MERSILENE. REPORTED COMPLICATIONS ARE: PROLENE MESH (ETHICON) -RESPIRATORY COMPLICATION (N=2 (2.2%) TREATMENT: NOT REPORTED -WOUND INFECTION SUPERFICIAL & DEEP (N=13 (14.9%) TREATMENT: ONE PATIENT REQUIRED RETURN TO THE OPERATING ROOM AND THE NEED TO REMOVE THE MESH AND THE OTHER TWO PATIENTS UNDERWENT ANTIBIOTIC THERAPY TO CONTROL INFECTION. ALL SUPERFICIAL WOUND INFECTION HEALED WITH ANTIBIOTICS AND LOCAL CARE. -MESH INFECTION (N=2 (2.3%) TREATMENT: MESH REMOVAL (N=1) -SEROMA (N=1 (1.1%)) TREATMENT: FLUID COLLECTION FINALLY RESOLVED ON ITS OWN. -INTESTINAL PARTIAL OBSTRUCTION (N=1 (1.1%) TREATMENT: NOT REPORTED MERSILENE MESH (ETHICON) -RESPIRATORY COMPLICATION (N=2 (2.2%) TREATMENT: NOT REPORTED -WOUND INFECTION SUPERFICIAL & DEEP (N=13 (14.9%) TREATMENT: ONE PATIENT REQUIRED RETURN TO THE OPERATING ROOM AND THE NEED TO REMOVE THE MESH AND THE OTHER TWO PATIENTS UNDERWENT ANTIBIOTIC THERAPY TO CONTROL INFECTION. ALL SUPERFICIAL WOUND INFECTION HEALED WITH ANTIBIOTICS AND LOCAL CARE. MESH INFECTION (N=2 (2.3%) TREATMENT: MESH REMOVAL (N=1) -SEROMA (N=1 (1.1%) TREATMENT: FLUID COLLECTION FINALLY RESOLVED ON ITS OWN. -INTESTINAL PARTIAL OBSTRUCTION (N=1 (1.1%) TREATMENT: NOT REPORTED IN CONCLUSION, THE R¿S TECHNIQUE IS THE MOST PROMISING OPEN TECHNIQUE, WITH LOW RECURRENCE RATES, EXCELLENT LONG-TIME RESULTS, AND MINIMAL SERIOUS MORBIDITY. AGE MIGHT BE AN IMPORTANT FACTOR IN RECURRENCE RA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353561 MERSILENE POLYESTER FIBER MESH MESH, SURGICAL FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention