BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAT DL 9.5 FR. 40 CC IAB

    MDR report key: 151843 · Received February 24, 1998

    Report

    Report Number
    2248146-1998-00207
    Event Type
    Injury
    Date Received
    February 24, 1998
    Date of Event
    December 25, 1997
    Report Date
    February 6, 1998
    Manufacturer
    DATASCOPE CORPORATION
    Product Code
    DSP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE IAB WAS INSERTED INTO THE PATIENT ON 12/24/1997 AT 1:00 P.M. AND REMOVED ON 12/25/1997 AT 5:30 P.M. THE IAB DID NOT MALFUNCTION. THE PATIENT HAD MAJOR ISCHEMIA AND REMOVAL OF THE IAB WAS REQUIRED. (EVENT COMPLICATIONS: MAJOR ISCHEMIA - REMOVAL REQUIRED - ) REPORTED 2/6/1998. (PT'S CURRENT STATUS: EXPIRED-RPT'D 2/6/1998. )

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAT DL 9.5 FR. 40 CC IAB INTRA-AORTIC BALLOON CATHETER DSP DATASCOPE CORPORATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Life Threatening| R