BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRLNE BLU 24IN 7-0 D/A BV175-8 MP

    MDR report key: 23064758 · Received September 16, 2025

    Report

    Report Number
    2210968-2025-10545
    Event Type
    Injury
    Date Received
    September 16, 2025
    Date of Event
    January 24, 2025
    Report Date
    September 16, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    UDI-DI
    10705031201903
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    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. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: ACTA OPHTHALMOL. 2025 JUN;103(4):461-468. DOI: 10.1111/AOS.17443. EPUB 2025 JAN 24. PMID: 39853904; PMCID: PMC12069969. HTTPS://DOI.ORG/10.1111/AOS.17443.

    Description of Event or Problem · 0

    ONE TUBE FOR ALL: 1-YEAR OUTCOMES AFTER TRANSITION TO PAUL GLAUCOMA IMPLANT AT A TERTIARY CENTRE. THE AIM OF THIS PROSPECTIVE OBSERVATIONAL STUDY WAS TO EVALUATE THE INTRAOCULAR PRESSURE (IOP) LOWERING EFFECT AND SUCCESS RATE OF PAUL GLAUCOMA IMPLANT (PGI) IN REFRACTORY GLAUCOMA AFTER CHANGING PRACTICE PATTERN FROM AHMED AND BAERVELDT TUBES TO PGI. FROM JANUARY 2022 TO OCTOBER 2023, A TOTAL OF 49 PATIENTS WERE INCLUDED IN THE STUDY. CONSISTS OF 38 MALE AND 11 FEMALE. WITH THE MEAN AGE OF 66.5 ± 16.9 AND RANGE 13¿85 YEARS. THE DEVICES USED DURING THE SURGERY WERE ETHILON 8¿0-9/0 (ETHICON),VICRYL 7¿0 (ETHICON) AND PROLENE 7¿0 (ETHICON) ,VISCOAT (ALCON LABORATORIES, TEXAS, USA) WAS INJECTED IN THE AC OR HEALON GV PRO (JOHNSON & JOHNSON, CALIFORNIA, USA) BEHIND THE IRIS IN CASES WITH PLACEMENT IN THE SULCUS. REPORTED COMPLICATIONS ETHILON 8¿0-9/0 (ETHICON), VICRYL 7¿0 (ETHICON), PROLENE 7¿0 (ETHICON) . LOSS OF ACUITY (N=?), TREATMENT: NOT REPORTED. CATARACT PROGRESSION (N=?) TREATMENT: NOT REPORTED. CLINICAL HYPOTONY (N=?) TREATMENT: NOT REPORTED. CHOROIDAL DETACHMENT (N=?) TREATMENT: NOT REPORTED. BCVA LOSS (N=?) TREATMENT: NOT REPORTED. MACULOPATHY (N=?) TREATMENT: NOT REPORTED. AC SHALLOWING (N=?) TREATMENT: NOT REPORTED. HYPHAEMA (N=?) TREATMENT: NOT REPORTED. CORNEAL DECOMPENSATION (N=?) TREATMENT: NOT REPORTED. IN CONCLUSIONS, THIS STUDY INDICATES THAT PGI PROVIDES A GOOD IOP-LOWERING EFFECT AFTER 12 MONTHS IN A POPULATION WITH RISK FACTORS FOR FAILURE FOR TRADITIONAL GLAUCOMA SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2679964 PRLNE BLU 24IN 7-0 D/A BV175-8 MP SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC. 10705031201903

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other