BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRUITT-INAHARA

    MDR report key: 149994 · Received January 20, 1998

    Report

    Report Number
    149994
    Event Type
    Other
    Date Received
    January 20, 1998
    Date of Event
    December 18, 1997
    Report Date
    December 29, 1997
    Manufacturer
    CRYOLIFE/IFM
    Product Code
    DQR
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DIFFICULTY WITH BALLOON INSUFFLATION. SECOND DEVICE OPENED-SURGEON HAD SAME PROBLEMS-DOUBLE INSUFFLATION AT ONCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRUITT-INAHARA OUTLYING "T" SHUNT DQR CRYOLIFE/IFM 400-40 1053097-36

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other