BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIRMAP CATHETER, 70MM

    MDR report key: 3764668 · Received April 10, 2014

    Report

    Report Number
    3008497357-2014-00002
    Event Type
    Injury
    Date Received
    April 10, 2014
    Manufacturer
    MEDFACT ENGINEERING GMBH
    Product Code
    MTD
    PMA / PMN Number
    K130827
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    A TOPERA EMPLOYEE WAS ON-SITE AT THE HOSPITAL AT THE TIME OF THE INCIDENT. HE REPORTED THE INCIDENT TO TOPERA INC. TOPERA WORKED WITH THE MANUFACTURER TO COMPLETE THE INVESTIGATION.

    Description of Event or Problem · 1

    REFERENCE IMPORTER # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216228 FIRMAP CATHETER, 70MM MAPPING CATHETER MTD MEDFACT ENGINEERING GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1