BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REDIGUT

    MDR report key: 4182110 · Received October 14, 2014

    Report

    Report Number
    1058382-2014-00001
    Event Type
    Injury
    Date Received
    October 14, 2014
    Date of Event
    August 7, 2014
    Report Date
    October 8, 2014
    Manufacturer
    SUTURES INDIA PVT. LTD.
    Product Code
    GAL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MULTIPLE PATIENTS HAD INFLAMMATION AT THE SUTURE SITE. PATIENTS WERE TREATED WITH ANTIBIOTICS AS A PRECAUTION FOR INJECTION, BUT INJECTION OF THE SITE WAS NOT CONFIRMED. THE SUTURES WERE REMOVED AFTER ONE WEEK BECAUSE THEY DID NOT DISSOLVE COMPLETELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649012 REDIGUT PLAIN CATGUT SUTURE GAL SUTURES INDIA PVT. LTD. GP821-SI MY40011

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other