BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 18773266 · Received February 23, 2024

    Report

    Report Number
    2210968-2024-01853
    Event Type
    Injury
    Date Received
    February 23, 2024
    Date of Event
    July 7, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (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? 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 H6 CLINICAL CODE: E2402 ¿ LACRIMAL PATENCY, RECURRENCE OF EPIPHORA THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. RELATED EVENTS CAPTURED VIA 2210968-2024-01852 AND 2210968-2024-01853 CITATION: HINDAWI JOURNAL OF OPHTHALMOLOGY VOLUME 2022,ARTICLE ID 2941283, 5 PAGES/ HTTPS://DOI.ORG/ 1 O. L L 55/2022/2941283

    Description of Event or Problem · 0

    TITLE: SUCCESS RATE COMPARIS ON OF EXTERNAL DACRYOCYSTORHINOSTOMY WITH 5-FU APPLICATION OR SILICONE TUBE INTUBATION THE AIM OF THE STUDY WAS TO COMPARE ANATOMICAL AND FUNCTIONAL SUCCESS RATES IN PATIENTS WITH PRIMARY ACQUIRED NASOLACRIMAL DUCT OBSTRUCTION UNDERGOING EXTERNAL DACRYOCYSTORHINOSTOMY (EX-DCR) EITHER WITH ADJUNCTIVE 5 FLUOROURACIL (5-FU) OR SILICONE TUBE INTUBATION. IN THIS RETROSPECTIVE COMPARATIVE STUDY, 37 EYES IN 32 PATIENTS (22 FEMALE, 10 MALE) WITH A MEAN AGE OF 40-80 YEARS OLD WHO UNDERWENT EX-DCR WITH ADJUNCTIVE 5-FU (5-FU GROUP) AND 43 EYES IN 40 PATIENTS (28 FEMALE, 12 MALE) WITH A MEAN AGE OF 15-80 YEARS OLD WHO UNDERWENT EX-DCR WITH SILICONE INTUBATION (CONTROLS) BETWEEN 2018 AND 2019 WERE INCLUDED. AFTER APPLICATION OF THE 5-FU AND INTUBATION, THE ANTERIOR MUCOSAL FLAPS WERE SUTURED USING INTERRUPTED 6.0 VICRYL SUTURES (ETHICON) AND UPON COMPLETION OF THE MUCOSAL ANASTOMOSIS, THE SKIN FLAPS WERE SUTURED WITH 6.0 POLYPROPYLENE (PROLENE) SUTURE (ETHICON). REPORTED COMPLICATIONS ARE LACRIMAL PATENCY AND RECURRENCE OF EPIPHORA. IN CONCLUSION, BOTH EX-DCR PROCEDURES WERE EFFECTIVE IN THE MANAGEMENT OF NASOLACRIMAL DUCT OBSTRUCTION. OUR RESULTS SUGGEST THAT EX-DCR AUGMENTED WITH 5-FU MAY REPRESENT A MORE FEASIBLE AND COST-EFFECTIVE THERAPEUTIC OPTION AS COMPARED TO SILICONE TUBE PLACEMENT IN THESE PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129203 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other