BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOXYL

    MDR report key: 3984227 · Received June 20, 2014

    Report

    Report Number
    3004060107-2014-00001
    Event Type
    Malfunction
    Date Received
    June 20, 2014
    Date of Event
    March 13, 2014
    Report Date
    June 20, 2014
    Manufacturer
    PETERS SURGICAL
    Product Code
    GAT
    PMA / PMN Number
    K060163
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER SAID: NOTE 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. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364334 CARDIOXYL NONABSORBABLE SUTURE GAT PETERS SURGICAL NA 956930

    Patients

    Seq Age Sex Outcome Treatment
    1