BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE HERNIA SYSTEM MESH UNKNOWN PRODUCT

    MDR report key: 21882873 · Received April 22, 2025

    Report

    Report Number
    2210968-2025-04149
    Event Type
    Injury
    Date Received
    April 22, 2025
    Date of Event
    January 7, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K984220
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    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. AN ATTEMPT HAS BEEN 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? D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. 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. CITATION: ACTA MED PORT. 2024 JUL 1;37(7-8):507-517. DOI: 10.20344/AMP.20277. PMID: 38950617. HTTPS://PUBMED.NCBI.NLM.NIH.GOV/38950617/.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: THE AIM OF THIS STUDY IS TO COMPARE CHRONIC POSTOPERATIVE PAIN IN PATIENTS UNDERGOING OPEN MESH REPAIR OF INGUINAL HERNIA BY LICHTENSTEIN VERSUS OTHER TECHNIQUES. EACH PARTICIPATING HOSPITAL INCLUDED CONSECUTIVE PATIENTS BEING OPERATED ON DURING ONE OR MORE PERIODS OF 14- DAYS (B)(6) 2019). AMONG THE PATIENTS INCLUDED IN THE STUDY, EIGHT PATIENTS UNDERWENT OTHER TECHNIQUE USING PROLENE HERNIA SYSTEM (PHS). REPORTED COMPLICATIONS ARE CHRONIC POSTOPERATIVE INGUINAL PAIN, POSTOPERATIVE COMPLICATIONS (N=?). IN CONCLUSION, THE LICHTENSTEIN TECHNIQUE WAS NOT ASSOCIATED WITH LOWER CPIP AND SHOWED COMPARABLE SURGICAL COMPLICATIONS. HOWEVER, OTHER FACTORS, SUCH AS THE RECURRENCE RATE (NOT ASSESSED HERE), MAY AFFECT THESE CONCLUSIONS IF BETTER OUTCOMES WITH THE LICHTENSTEIN TECHNIQUE WERE TO BE DEMONSTRATED. FURTHER STUDIES WITH LONG-TERM OUTCOMES ARE NECESSARY TO IMPROVE THE KNOWLEDGE OF LONG-TERM PAIN AND RECURRENCE RATES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1261032 PROLENE HERNIA SYSTEM MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other