BEUDAMED
    FDA Adverse Event Summary report: N

    CARDIOXYL SUTURE

    MDR report key: 3937441 · Received June 23, 2014

    Report

    Report Number
    3006785471-2014-00001
    Date Received
    June 23, 2014
    Date of Event
    March 12, 2014
    Report Date
    June 20, 2014
    Manufacturer
    PETERS SURGICAL
    Product Code
    GAT
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE SUTURE COATING APPEARED TO BE FLAKING OFF THE SUTURE. CUSTOMER FURTHERMORE REPORTED THAT THE AFFECTED PRODUCT WAS NOT USED ON THE PT. PLEASE REFERENCE MANUFACTURER REPORT NUMBER 3004060107-2014-00001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364578 CARDIOXYL SUTURE NONABSORBABLE SUTURE GAT PETERS SURGICAL 73P35E 956930

    Patients

    Seq Age Sex Outcome Treatment
    1