BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHICON, INC., VICRYL

    MDR report key: 2627249 · Received June 19, 2012

    Report

    Report Number
    MW5025912
    Event Type
    Injury
    Date Received
    June 19, 2012
    Date of Event
    May 15, 2012
    Report Date
    June 19, 2012
    Manufacturer
    ETHICON INC
    Product Code
    GAM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012, NURSE PRACTITIONER REPORTED THAT PT IS HAVING AN ALLERGIC "SPITTING" SUTURE REACTION TO VICRYL SUTURE, USED (B)(6) 2012, FOR PT'S APPENDECTOMY SURGERY. ON (B)(6) 2012, PT ALSO EXPERIENCED PAIN EQUAL TO SURGERY PAIN, AND REQUIRED ANTIBIOTICS AND ADD'L PAIN MEDICATION FOR INFECTION AT SUTURE SIGHTS. PT'S ACTIVITIES ARE STILL LIMITED WITH PT BEING MORE ACTIVE JUST ONE WEEK AFTER SURGERY BEFORE SUTURES WERE DISSOLVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON, INC., VICRYL VICRYL SUTURE GAM ETHICON INC

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Disability