BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCERTO DETACHABLE COIL SYSTEM

    MDR report key: 11731345 · Received April 27, 2021

    Report

    Report Number
    11731345
    Event Type
    Malfunction
    Date Received
    April 27, 2021
    Date of Event
    April 21, 2021
    Report Date
    April 22, 2021
    Manufacturer
    MICRO THERAPEUTICS, INC.
    Product Code
    KRD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DEPLOYED INCORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630425 CONCERTO DETACHABLE COIL SYSTEM DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD MICRO THERAPEUTICS, INC. PV-12-40-HELIX A650957

    Patients

    Seq Age Sex Outcome Treatment
    1 24090 DA