BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 19070579 · Received April 9, 2024

    Report

    Report Number
    2210968-2024-04075
    Event Type
    Injury
    Date Received
    April 9, 2024
    Date of Event
    June 1, 2022
    Report Date
    April 9, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. AS NO CONTACT INFORMATION HAS BEEN PROVIDED, NO FOLLOW UP CAN OR WILL BE PERFORMED AT THIS TIME. 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. CITATION: INVESTIGATIVE OPHTHALMOLOGY & VISUAL SCIENCE JUNE 2022, VOL.63, 3711 ¿ (B)(6).

    Description of Event or Problem · 0

    TITLE: THE APPLICATION OF COLLAGEN MATRIX TO REVERSE HYPOTONY FOLLOWING TRABECULECTOMY WITH MITOMYCIN C. THE PURPOSE OF THE STUDY IS TO ASSESS THE ROLE OF COLLAGEN MATRIX IN REVERSING OCULAR HYPOTONY FOLLOWING TRABECULECTOMY. FROM (B)(6) 2019 TO (B)(6) 2021, 11 EYES OF 11 PATIENTS WHO REQUIRED SURGICAL REVISION DUE TO HYPOTONY FOLLOWING TRABECULECTOMY WERE INCLUDED IN THE STUDY. MEAN PATIENT AGE WAS 71.3±7.5 YEARS AND MEAN FOLLOW-UP DURATION WAS 110.8±78.6 DAYS (RANGE 22-247). DURING THE PROCEDURE, THE CONJUNCTIVA WAS HORIZONTALLY INCISED APPROXIMATELY 8-MM POSTERIOR TO THE LIMBUS. CONJUNCTIVA AND TENON WERE DISSECTED ANTERIORLY TO THE LIMBUS. THE COLLAGEN MATRIX WAS PLACED OVERLYING THE PRIOR TRABECULECTOMY SITE. THE INCISION WAS CLOSED USING AN 8-0 VICRYL (ETHICON) SUTURE IN A RUNNING FASHION. REPORTED COMPLICATIONS INCLUDED BLEB LEAK (N=3), AND PERSISTENT CORNEAL EDEMA (N=1). IN CONCLUSION, OUR INITIAL EXPERIENCE WITH COLLAGEN MATRIX SHOWS PROMISE AS AN EFFECTIVE METHOD OF REVERSING HYPOTONY WHILE MAINTAINING THERAPEUTIC IOP LEVELS. ADDITIONALLY, IT WAS ALSO EFFECTIVE IN REVERSING LEAKS ASSOCIATED WITH THIN-WALLED CYSTIC BLEBS WITHOUT THE NEED FOR ADDITIONAL TISSUE MANIPULATION. NO SURGICAL FAILURES WERE RECORDED. OUR FINDINGS ARE CONSISTENT WITH PREVIOUSLY PUBLISHED LITERATURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2270181 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention