BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 22664900 · Received July 30, 2025

    Report

    Report Number
    2210968-2025-08815
    Event Type
    Injury
    Date Received
    July 30, 2025
    Date of Event
    August 25, 2023
    Report Date
    July 30, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. AS NO CONTACT INFORMATION HAS BEEN PROVIDED, NO FOLLOW UP CAN OR WILL BE PERFORMED AT THIS TIME. SHOULD FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. 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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. 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: INTERNATIONAL JOURNAL OF CURRENT PHARMACEUTICAL REVIEW AND RESEARCH 2023; 15(09); 516-519 DOI: NOT PROVIDED.

    Description of Event or Problem · 0

    TITLE: A COMPARATIVE STUDY OF ONLAY VERSUS RETRORECTUS MESH PLACEMENT IN INCISIONAL HERNIA REPAIR. THE AIM OF THIS STUDY IS TO EVALUATE & COMPARE THE EFFICACY OF ONLAY MESH REPAIR AND RETRORECTUS MESH PLACEMENT FOR REPAIR OF INCISIONAL HERNIA. BETWEEN NOVEMBER 2021 TILL AUGUST 2023, A TOTAL OF 60 RECRUITED PATIENTS WITH MIDLINE HERNIAS UP TO 10 CM IN DIAMETER, WHO WERE ADMITTED TO THE GENERAL SURGERY DEPARTMENT OF OUR TERTIARY CARE HOSPITAL. PATIENTS WERE RANDOMIZED INTO TWO GROUPS. GROUP A ¿ PATIENTS WHO HAD UNDERGONE TRADITIONAL ON-LAY MESH REPAIR (N=30); GROUP B - INCLUDED PATIENTS WHO HAD UNDERGONE RETRO-RECTUS MESH REPAIR (N=30). AGE : GROUP A (55.47PLUS OR MINUS 11.92), GROUP B (53.58PLUS OR MINUS 13.20); GENDER (M, F) : GROUP A (9,21), GROUP B (11,19). IN TRADITIONAL ON-LAY MESH REPAIR A PROLENE MESH (ETHICON) WAS CUT 5 MM OVERSIZED OF THE DEFECT & SUTURED LONGITUDINALLY USING (2.0) POLYPROPYLENE SUTURE TO THE EXPOSED ANTERIOR SHEATH OR EXTERNAL OBLIQUE FASCIA ON THE LATERAL SIDES. WHILE IN RETRO-RECTUS MESH REPAIR A PROLENE MESH (ETHICON) WAS CUT MEASURING THE DEFECT WITH A 5-CM OVERLAP, WHICH WAS THEN PLACED BETWEEN THE POSTERIOR RECTUS SHEATH AND RECTUS MUSCLE ABOVE THE ARCUATE LINE, AND IN THE PRE-PERITONEAL SPACE BELOW THE ARCUATE LINE. REPORTED COMPLICATIONS ARE: -SEROMA (N=9). -DEEP SURGICAL SITE INFECTIONS (N=3). IN CONCLUSION, THE RECTORECTUS MESH REPAIR TECHNIQUE IS ASSOCIATED WITH LOW POSTOPERATIVE PAIN SCORES & FEWER POSTSURGICAL COMPLICATIONS & THUS LESS NUMBER OF HOSPITALIZATION DAYS. RECTORECTUS MESH REPAIR TECHNIQUE IN THE MANAGEMENT OF INCISIONAL HERNIA IS SUPERIOR TO ONLAY (TRADITIONAL) MESH REPAIR TECHNIQUE. ADDITIONALLY, LONG-TERM FOLLOW-UP STUDIES SHOULD BE UNDERTAKEN INTO ACCOUNT THE ISSUES OF DELAYED WOUND HEALING & RECURRENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548773 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other