BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 22663793 · Received July 30, 2025

    Report

    Report Number
    2210968-2025-08794
    Event Type
    Injury
    Date Received
    July 30, 2025
    Date of Event
    January 1, 2024
    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. 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. 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: JOURNAL OF CARDIOVASCULAR DISEASE RESEARCH, VOL 15, ISSUE 01, 2024 (PUBMED CITATION NOT PROVIDED). PLEASE SEE ARTICLE ATTACHED.

    Description of Event or Problem · 0

    TITLE: COMPARATIVE STUDY OF OPEN HERNIA REPAIR WITH LICHTENSTEIN PROCEDURE V/S SELF GRIPPING SEMI REABSORBABLE MESH THE AIM OF THIS STUDY WAS TO TEST THE PRINCIPLE OF SELF-FIXATION MESH APPLICATION. A TOTAL OF (B)(4) PATIENTS WHO UNDERWENT INGUINAL HERNIA REPAIR WERE INCLUDED IN THE STUDY. MAXIMUM PATIENTS WERE BETWEEN 51-65 YEARS OF AGE FOLLOWED BY 36-50 YEARS OF AGE GROUP. AMONG THESE, (B)(4) PATIENTS WERE MANAGED BY PROLENE MESH FIXED BY SUTURE AND (B)(4) PATIENTS MANAGED BY PROGRIP MESH. REPORTED COMPLICATIONS INCLUDE MODERATE TO SEVERE PAIN (N=?) AND WOUND INFECTION (N=?). IN CONCLUSION, THE POINT OF OUR INVESTIGATION IS TO THINK ABOUT THE RESULT AFTER LICHTENSTEIN'S INGUINAL HERNIA FIX UTILIZING ORDINARY LATTICE V/S SELF-FOCUSING PRO GRASP NETWORK. THE ESSENTIAL ENDPOINT OF THE EXAMINATION WILL BE THE OCCURRENCE OF POST-OPERATIVE PAIN. OPEN INGUINAL HERNIOPLASTY UTILIZING SELF GRIPPING MESH (PRO HOLD) HAS BETTER RESULT AS FAR AS USABLE TIME, POST-USABLE TORMENT, HOSPITAL STAY, EARLY RE-VISITATION OF EXPERT LIFE AND ONGOING AGONY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45811 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other