BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAT DL 9.5 FR. 40 CC. IAB

    MDR report key: 191089 · Received October 10, 1998

    Report

    Report Number
    2248146-1998-01168
    Event Type
    Injury
    Date Received
    October 10, 1998
    Date of Event
    July 12, 1997
    Report Date
    September 24, 1998
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE IAB WAS INSERTED INTO THE PT ON 07/11/1997 AT 8:28 P.M. AND REMOVED ON 07/12/1998 AT 9:50 A.M. THE IAB DID NOT MALFUNCTION. THE PT HAD MAJOR ISCHEMIA AND REMOVAL OF THE IAB WAS REQUIRED. EVENT COMPLICATIONS: MAJOR ISCHEMIA/REMOVAL REQUIRED - REPORTED 09/24/1998. PT'S CURRENT STATUS: DISCHARGED - REPORTED 09/24/1998.

    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 CORP. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention