BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIOXYL SUTURE

    MDR report key: 3695650 · Received March 19, 2014

    Report

    Report Number
    MW5035125
    Event Type
    Injury
    Date Received
    March 19, 2014
    Date of Event
    March 13, 2014
    Report Date
    March 18, 2014
    Manufacturer
    PETERS SURGICAL
    Product Code
    GAT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NOTED COATING ON CARDIOXYL SUTURE PEELING OFF DURING AORTIC ROOT REPLACEMENT SURGERY. A DIFFERENT SUTURE WAS USED FOR THE PT AND ALL SUTURES WITH THIS LOT NUMBER WERE PULLED FROM STOCK AND FOLLOW UP WITH MANUFACTURER. DIAGNOSIS OR REASON FOR USE: CARDIAC SURGERY PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161998 CARDIOXYL SUTURE SUTURE GAT PETERS SURGICAL 956930

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention