BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 23057964 · Received September 15, 2025

    Report

    Report Number
    2210968-2025-10511
    Event Type
    Injury
    Date Received
    September 15, 2025
    Date of Event
    January 1, 2025
    Report Date
    September 15, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    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 BE PROVIDED, THE FILE WILL BE UPDATED ACCORDINGLY. IF 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 LIFE SCIENCES, BIOTECHNOLOGY AND PHARMA RESEARCH VOL. 14, NO. 1, JANUARY 2025 ONLINE ISSN: 2250-3137 PRINT ISSN: 2977-0122 HTTPS://DOI.ORG/10.69605/IJLBPR_14.1.2025.95 PLEASE SEE ARTICLE ATTACHED.

    Description of Event or Problem · 0

    TITLE: A COMPARATIVE STUDY OF ENDOSCOPIC ENDONASAL DACRYOCYSTORHINOSTOMY WITH AND WITHOUT PROLENE STENTING. THE AIM OF THIS STUDY WAS TO COMPARE THE RESULTS OF ENDOSCOPIC DCR WITH AND WITHOUT PROLENE STENTING AND TO ASSESS THE USAGE OF PROLENE AS STENTING MATERIAL IN EN DCR. A TOTAL OF 50 CASES INCLUDED IN THE STUDY. DIVIDED INTO TWO GROUPS: GROUP A (N=25). 20 FEMALE AND 5 MALE. GROUP B (N=25) CONSIST OF 21 FEMALE AND 4 MALE. AGE OF THE PATIENTS RANGED FROM 24-81 YRS WITH MOST OF THE PATIENTS IN AGE GROUP OF 41-50 YRS (30% N=15, 9 IN GROUP A AND 6 IN GROUP B). THE MEAN AGE OF PRESENTATION IS 49.18 YRS. PROLENE STENT (ETHICON) IN ENDCR WAS USED IN GROUP A. WITHOUT STENT IN GROUP B. REPORTED COMPLICATIONS PROLENE STENT (ETHICON) -WITH FAILURE IN GRANULATION TISSUE AROUND THE STENT (N=1) TREATMENT: NOT REPORTED -THERE WAS CLOSURE OF THE RHINOSTOMAL OPENING (N=1) TREATMENT: NOT REPORTED -MINOR BLEEDING (N=2) TREATMENT: MANAGED WITH STEROID EYE DROPS AND ANTIBIOTICS -GRANULATION TISSUE AT THE STOMA (N=1) TREATMENT: NOT REPORTED -OCULAR IRRITATION (N=3) TREATMENT: NOT REPORTED IN CONCLUSIONS, ENDOSCOPIC DCR HAS A GOOD SUCCESS RATE WITH AND WITHOUT NASOLACRIMAL STENTING. PROLENE AS A STENTING MATERIAL IS EFFECTIVE IN PRIMARY CASES WITH NASOLACRIMAL DUCT OBSTRUCTION. IT CAN BE USED AS AN ALTERNATIVE TO SILICONE, ESPECIALLY IN SETTINGS WITH LIMITED RESOURCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2022239 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention