BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NYLON SUTURE UNKNOWN PRODUCT

    MDR report key: 24318856 · Received February 11, 2026

    Report

    Report Number
    2210968-2026-01553
    Event Type
    Injury
    Date Received
    February 11, 2026
    Date of Event
    June 21, 2025
    Report Date
    February 11, 2026
    Manufacturer
    ETHICON INC.
    Product Code
    GAR
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    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. 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: J CLIN MED. 2025 JUN 21;14(13):4426. HTTPS://DOI.ORG/10.3390/JCM14134426. PMID: 40648800; PMCID: PMC12249493.

    Description of Event or Problem · 0

    TITLE: COMPARISON OF XEN45 GEL STENT OUTCOMES IN GLAUCOMA: AB EXTERNO OPEN-CONJUNCTIVA APPROACH WITH OLOGEN VS. AB INTERNO CLOSED-CONJUNCTIVA APPROACH. THE AIM OF THIS STUDY IS TO EVALUATED THE EFFICACY AND SAFETY OF THE AB EXTERNO OPEN-CONJUNCTIVA (AEO) APPROACH WITH ADJUNCTIVE OLOGEN COLLAGEN MATRIX (OCM) COMPARED TO AB INTERNO CLOSED-CONJUNCTIVA (AIC) TECHNIQUES FOR XEN45 GEL STENT IMPLANTATION IN PATIENTS WITH REFRACTORY OPEN-ANGLE GLAUCOMA. THE GOAL WAS TO DETERMINE WHETHER THE AEO WITH OCM APPROACH OFFERS ADVANTAGES IN INTRAOCULAR PRESSURE (IOP) CONTROL AND POST OPERATIVE OUTCOMES. THE PATIENTS WERE DIVIDED INTO GROUP 1 (AEO WITH OCM, N = 47) AND GROUP 2 (AIC, N = 29). 8-0 VICRYL (ETH) WAS USED TO CLOSED THE CONJUNCTIVAL PERITOMY, WHILE 10-0 NYLON (ETH) WAS USED TO REFORMED WITH A BALANCED SALT SOLUTION BEFORE SUTURING THE CLEAR CORNEAL WOUND. REPORTED COMPLICATIONS: 8-0 VICRYL (ETH) 10-0 NYLON (ETH). INTRAOCULAR PRESSURE (IOP)ELEVATION>30MMH (N=?) TREATMENT: NOT REPORTED HYPHEMA (N=?) TREATMENT: NOT REPORTED IRIS OBSTRUCTION OF THE STENT (N=?) TREATMENT: NOT REPORTED REBOUND IRITIS (N=?) TREATMENT: NOT REPORTED WOUND LEAK (N=?) TREATMENT: NOT REPORTED CHOROIDAL EFFUSIONS (N=?) TREATMENT: NOT REPORTED HYPOTONY MACULOPATHY (N=?) TREATMENT: NOT REPORTED CORNEAL DECOMPENSATION (N=?) TREATMENT: NOT REPORTED SYMPTOMATIC BLEB EXTENSION (N=?) TREATMENT: NOT REPORTED CYSTOID MACULAR EDEMA (N=?) TREATMENT: NOT REPORTED CORNEAL ABRASION (N=?). TREATMENT: NOT REPORTED. IN CONCLUSIONS, THE AEO WITH OCM APPROACH TO XEN4 5IMPLANTATION MAY PROVIDE IMPROVED SAFETY AND EFFICACY COMPARED TO THE AIC APPROACH. IT APPEARS TO BE BENEFICIAL IN MINIMIZING POSTOPERATIVE FIBROSIS, REDUCING THE MEDICATION BURDEN, AND LOWERING COMPLICATION AND FAILURE RATES. PROSPECTIVE RANDOMIZED TRIALS ARE NEEDED TO VALIDATE THESE FINDINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373653 NYLON SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC GAR ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other