BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCOR STAT DL 9.5 FR. 40 CC IAB

    MDR report key: 72775 · Received February 27, 1997

    Report

    Report Number
    2248146-1997-00111
    Event Type
    Injury
    Date Received
    February 27, 1997
    Date of Event
    January 23, 1997
    Report Date
    January 28, 1997
    Manufacturer
    DATASCOPE CORPORATION
    Product Code
    DSP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE IAB WAS INSERTED INTO THE PT ON 1/21/97 AND REMOVED ON 1/23/97. THE IAB DID NOT MALFUNCTION. AS A RESULT OF THE EVENT, THE PT HAD A THROMBOSIS AND AN ISCHEMIC COMPLICATION. EVENT COMPLICATIONS: THROMBOSIS AND ISCHEMIC COMPLICATION - REPORTED 1/28/97. PT'S CURRENT STATUS: EXPIRED - RPT'D 1/28/97.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCOR STAT DL 9.5 FR. 40 CC IAB INTRA-AORTIC BALLOON CATHETER DSP DATASCOPE CORPORATION 0684-00-0306 06/07/98

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Life Threatening| R