BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL SUTURES

    MDR report key: 5924628 · Received August 30, 2016

    Report

    Report Number
    MW5064508
    Event Type
    Injury
    Date Received
    August 30, 2016
    Manufacturer
    ETHICON
    Product Code
    GAM
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ONE MONTH AFTER HAVING MOH'S SURGERY ON THE RIGHT TEMPLE AREA OF MY FACE, MY BODY BEGAN REJECTING THE SUBCUTICULAR VICRYL SUTURES MANUFACTURED BY ETHICON. THIS STARTED WITH A PUSTULE WHICH CAME TO A HEAD AND DRAINED PUS AND BLOOD FOLLOWED BY SECTIONS OF SUTURE MATERIAL WHICH WERE PULLED OUT. THIS OCCURRED SUCCESSIVELY ALONG FIVE AREAS OF THE 3 1/4 INCH WOUND WITH A TOTAL OF 6 SEGMENTS OF VICRYL SUTURE REMOVED. I WAS SEEN BY MY MOH'S SURGEON WHO TOLD ME THAT REJECTION OCCURS IN 20-30 PERCENT OF CASES. THIS HAS CAUSED DELAY IN WOUND HEALING AND A FEW SCARS ALONG THE SUTURE LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567405 VICRYL SUTURES VICRYL SUTURES GAM ETHICON

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR CALCIUM/MAGNESIUM| HYDROXYAPATITE| OTC MEDS: FISH OIL| RX MEDS: NONE| UBIQUINOL WITH PQQ| VIT D3