BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNTEL RT-EMB, 4F-80CM

    MDR report key: 751810 · Received August 17, 2006

    Report

    Report Number
    2027111-2006-00023
    Event Type
    Injury
    Date Received
    August 17, 2006
    Date of Event
    April 18, 2006
    Report Date
    July 17, 2006
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    DXE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    "THE CATHETER FELT ROUGHER THAN NORMAL, AND CAUSED THE PUNCTURE OF THE VESSEL. (LOT # 137601) AND (LOT # 1000876). NO SAMPLES BEING RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNTEL RT-EMB, 4F-80CM EMBOLECTOMY CATHETER DXE APPLIED MEDICAL RESOURCES A4405 137601

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization