BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT DL 9.5 FR. 34 CC. IAB

    MDR report key: 132697 · Received November 13, 1997

    Report

    Report Number
    2248146-1997-01243
    Event Type
    Malfunction
    Date Received
    November 13, 1997
    Report Date
    November 10, 1997
    Manufacturer
    DATASCOPE CORPORATION
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: A USER CARTON, LABELED AS CONTAINING IAB S/N I1124815, WAS RETURNED FOR EVAL. VISUAL INSPECTION OF THE CARTON CONTENTS REVEALED AN UNUSED, SEALED INSERTION KIT, LOT AAJ. THERE WAS USER DOCUMENTATION IN THE CARTON. NO IAB WAS OBSERVED TO BE PRESENT WITHIN THE BOX. (THIS FOLLOW-UP MDR WAS MAILED TO THE FDA ON 1/6/98).

    Description of Event or Problem · 1

    THERE WAS NO IAB IN THE USER CARTON WHEN THE BOX WAS OPENED. THERE WAS ONLY AN INSERTION KIT. (EVENT COMPLICATIONS: UNK-REPORTED 11/11/97.) (PT'S CURRENT STATUS: UNK-RPT'D 11/11/97.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAT DL 9.5 FR. 34 CC. IAB INTRA-AORTIC BALLOON CATHETER DSP DATASCOPE CORPORATION 0684-00-0206-01 07/03/99

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN