BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAT DL 9.5 FR. 40 CC. IAB

    MDR report key: 146736 · Received January 28, 1998

    Report

    Report Number
    2248146-1998-00056
    Event Type
    Injury
    Date Received
    January 28, 1998
    Date of Event
    January 12, 1998
    Report Date
    January 15, 1998
    Manufacturer
    DATASCOPE CORP
    Product Code
    DSP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE IAB WAS INSERTED INTO THE PT ON 1/12/1998 AT 12:02 P.M. AND REMOVED ON 1/12/1998 AT 9:00 P.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 1/15/1998. (PT'S CURRENT STATUS: UNK - RPT'D 1/15/1998.)

    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 0684-00-0283 5/22/1999

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention