BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 18799136 · Received February 28, 2024

    Report

    Report Number
    2210968-2024-02091
    Event Type
    Injury
    Date Received
    February 28, 2024
    Date of Event
    November 29, 2022
    Report Date
    February 28, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    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. CITATION: COMPARISON OF SURGICAL TREATMENT RESULTS OF LARGE INCISIONAL HERNIAS. HTTPS://DOI.ORG/10.7759/CUREUS.32020.

    Description of Event or Problem · 0

    TITLE: COMPARISON OF SURGICAL TREATMENT RESULTS OF LARGE INCISIONAL HERNIAS. THE AIM OF THIS STUDY IS TO COMPARE THE RESULTS OF THE THREE MOST COMMON SURGICAL TREATMENT METHODS USED IN A TERTIARY UNIVERSITY HOSPITAL FOR THE REPAIR OF LARGE INCISIONAL HERNIAS IN TERMS OF PATIENTS' CHARACTERISTICS, RECURRENCE, AND COMPLICATION RATES OF THE TREATMENT METHODS. BETWEEN 2014 AND 2020, 366 PATIENTS WITH INCISIONAL HERNIAS WITH FACIAL DEFECTS LARGER THAN 10 CM IN A TERTIARY MEDICAL FACULTY HOSPITAL LOCATED IN EASTERN TURKEY WERE ANALYZED. PATIENTS WERE DIVIDED INTO THREE GROUPS ACCORDING TO THE SURGICAL METHOD USED: OPEN ONLAY PROLENE MESH (OPM) METHOD, LAPAROSCOPIC INTRAPERITONEAL SUBLAY DUAL MESH (IPSDM) METHOD, AND OPEN IPSDM METHOD. PROPYLENE MESH WAS USED IN THE OPEN OPM TECHNIQUE AND DUAL-COMPOSITE MESH WAS USED IN THE LAPAROSCOPIC IPSDM AND OPEN IPSDM TECHNIQUES. REPORTED COMPLICATION: SEROMA (N-42). BLEEDING (N-5). SUPERFICIAL WOUND INFECTION (N-25). SKIN EROSION (N-10). SKIN NECROSIS (N-2). MESH REACTION (N-3). ENTEROCUTANEOUS FISTULA (N- 1). RECURRENCE (N-28). CONCLUSIONS ALTHOUGH HERNIA DEFECT IS GREATER IN THE OPEN IPSDM COMPARED TO OTHER METHODS, THIS METHOD IS MORE ADVANTAGEOUS IN TERMS OF THE COMPLICATION RATE ASSOCIATED WITH THE SURGICAL PROCEDURE, THE OVERALL COMPLICATION RATE, THE DURATION OF SURGERY, AND THE RECURRENCE RATE. LAPAROSCOPIC IPSDM IS A MORE ADVANTAGEOUS METHOD IN TERMS OF THE OVERALL WOUND AND MEDICAL COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445187 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention