BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 23121608 · Received September 23, 2025

    Report

    Report Number
    2210968-2025-10834
    Event Type
    Injury
    Date Received
    September 23, 2025
    Date of Event
    May 14, 2024
    Report Date
    September 23, 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
    NL
    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: ACTA OPHTHALMOL. 2024 DEC;102(8):963-967. HTTPS://DOI.ORG/10.1111/AOS.16735. EPUB 2024 JUL 2. PMID: 38953540.

    Description of Event or Problem · 0

    TITLE: RETROSPECTIVE STUDY IN 1020 CASES ON THE RATE OF SURGICAL SITE INFECTIONS AFTER LACRIMAL SURGERY WITHOUT PROPHYLACTIC SYSTEMIC ANTIBIOTICS. THE AIM OF THIS STUDY IS TO DETERMINE THE POSTOPERATIVE SURGICAL SITE INFECTION (SSI) RATE IN LACRIMAL SURGERY WITHOUT PSA. BETWEEN JANUARY 2001 TO MAY 2005 AND FROM AUGUST 2013 TO DECEMBER 2016, A TOTAL OF 1020 SURGERIES WERE PERFORMED IN 899 PATIENTS: WHO UNDERWENT EXTERNAL (N=747) (EXTDCR) OR ENDOSCOPIC ENDONASAL DACRYOCYSTORHINOSTOMY (ENDODCR) (N=273). IN THE ENDONASAL DCR GROUP, SPONGOSTAN (ETHICON) WAS USED IN CASES WITH MORE SEVERE BLEEDING. IN THE EXTERNAL DCR GROUP, THE ANTERIOR LACRIMAL SAC FLAP WAS CONNECTED WITH THE U-SHAPED NASAL MUCOSA FLAP USING TWO VICRY (POLYGLACTIN 910) RAPID 6-0 SUTURES. THE SKIN WAS CLOSED WITH EITHER NON-RESORBABLE PROLENE (POLYPROPYLENE) 6-0 OR FAST ABSORBING VICRYL RAPID 6-0. REPORTED COMPLICATIONS ARE EXTDCR GROUP: N=1; 46-YEAR-OLD-FEMALE WOUND INFECTION TREATMENT: ORAL AMOXICILLIN/CLAVULANIC ACID IN CONCLUSION, THE PREVALENCE OF SSI AFTER DCR IS LOW AND WAS EFFECTIVELY TREATED WITH ORAL ANTIBIOTICS. IN OUR STUDY, SSI OCCURRED RARELY AFTER EXTDCR AND WAS NOT OBSERVED AFTER ENDODCR. WE CONCLUDE THAT LACRIMAL SURGERY IS SAFE WITHOUT THE ROUTINE ADMINISTRATION OF PSA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196240 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Required Intervention