BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 22328494 · Received June 25, 2025

    Report

    Report Number
    2210968-2025-07396
    Event Type
    Injury
    Date Received
    June 25, 2025
    Date of Event
    July 9, 2024
    Report Date
    June 25, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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: EYE (LOND). 2024 NOV;38(16):3065-3071. HTTPS://DOI.ORG/10.1038/S41433-024-03219-6 EPUB 2024 JUL 9. PMID: 38982302; PMCID: PMC11544244.

    Description of Event or Problem · 0

    TITLE: AQUEOUS SHUNT EXPOSURE REPAIR: OUTCOMES AND RISK FACTORS FOR RECURRENCE. THE AIM OF THIS STUDY IS TO INVESTIGATE THE SURVIVAL OF AQUEOUS SHUNT EXPOSURE REPAIR WITHOUT FURTHER EXPOSURE AND TO IDENTIFY RISK FACTORS FOR RECURRENCE OF EXPOSURE. BETWEEN 2010 AND 2018, A TOTAL OF 76 PATIENTS UNDERWENT REPAIR OF AN EXPOSED AQUEOUS SHUNT WHILE USING 8/0 VICRYL CONTINUOUS SUTURES. REPORTED COMPLICATIONS ARE N=1; ENDOPHTHALMITIS TREATMENT: NOT REPORTED N=1; FUSARIUM KERATITIS TREATMENT: EVISCERATION N=1; CORNEAL DECOMPENSATION TREATMENT: NOT REPORTED N=23; DEVELOPED FURTHER EXPOSURE TREATMENT: SURGICAL REPAIR IN CONCLUSION, AQUEOUS SHUNT EXPOSURE REVISION IS ASSOCIATED WITH REASONABLE MID AND LONG TERM SUCCESS. A SHORTER INTERVAL FROM TUBE INSERTION TO EXPOSURE REVISION, PREVIOUS REVISIONS AND THE USE OF A HUMAN PERICARDIUM PATCH WERE ASSOCIATED WITH INCREASED RISK OF FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1068753 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention