BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACUCISE RP 35, ACU-PACK

    MDR report key: 1572612 · Received January 5, 2010

    Report

    Report Number
    2027111-2010-00001
    Event Type
    Other
    Date Received
    January 5, 2010
    Date of Event
    December 28, 2009
    Report Date
    January 4, 2010
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    KOD
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AND EVAL OF THE INCIDENT DEVICE, A FINAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    "OBSTRUCTED-WOULD NOT ACCEPT GUIDEWIRE. ADD'L TIME REQUIRED STRUGGLING WITH DEVICE - TIME TO REASSEMBLE NEW DEVICE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUCISE RP 35, ACU-PACK ACUCISE CATHETER KOD APPLIED MEDICAL RESOURCES B1005 1059179

    Patients

    Seq Age Sex Outcome Treatment
    1