BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COATED VICRYL

    MDR report key: 17669468 · Received September 1, 2023

    Report

    Report Number
    17669468
    Event Type
    Malfunction
    Date Received
    September 1, 2023
    Date of Event
    March 30, 2023
    Report Date
    August 11, 2023
    Manufacturer
    ETHICON, LLC
    Product Code
    GAM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SHORELINE IS REPORTING THAT SEVERAL PATIENTS HAVE EXPERIENCED "INFLAMMATORY REACTION TO THE VICRYL SUTURE". THE SUTURE THAT WAS USED IN THESE CASES IS SUTURE VICRYL 7-0 TG140-8 18IN DA VIOLET. 4 PATIENTS (MRS NOTED IN ORIGINAL RL) NOTED TO HAVE REACTION TO 7-0 VICRYL SUTURE AFTER EYE SURGERY. SUTURE VICRYL 7-0 TG140-8 18IN DA VIOLET ETHJ546G 6270 MEDLINE INDUSTRIES INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1514910 COATED VICRYL SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID GAM ETHICON, LLC J546G, J494H

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown