BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTOBASE SUTURE HOLDER INSERT

    MDR report key: 536306 · Received March 19, 2004

    Report

    Report Number
    2135394-2004-00003
    Event Type
    Malfunction
    Date Received
    March 19, 2004
    Date of Event
    February 18, 2004
    Report Date
    February 19, 2004
    Manufacturer
    MEDTRONIC CARDIAC SURGERY TECHNOLOGIES
    Product Code
    DWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INFO RECEIVED INDICATES THAT A COMPONENT DETACHED FROM THE DEVICE DURING THE CASE WITHOUT PT INVOLVEMENT. ALTERNATIVE COMPONENTS WERE AVAILABLE AND THE DEVICE WAS USED THROUGHOUT THE CASE WITH NO REPORTED CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTOBASE SUTURE HOLDER INSERT SUTURE HOLDER INSERT DWS MEDTRONIC CARDIAC SURGERY TECHNOLOGIES 28707 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other