BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAT DL 9.5 FR. 40 CC. IAB

    MDR report key: 288657 · Received August 1, 2000

    Report

    Report Number
    2248146-2000-00010
    Event Type
    Injury
    Date Received
    August 1, 2000
    Date of Event
    June 23, 2000
    Report Date
    July 7, 2000
    Manufacturer
    DATASCOPE CORPORATION
    Product Code
    DSP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE IAB WAS INSERTED INTO THE PT IN 2000 AT 8:50 P.M. AND REMOVED 2 DAYS LATER AT 2:30 P.M. THE IAB DID NOT MALFUNCTION. THE PT HAD MINOR LIMB ISCHEMIA AND RENAL FAILURE. THE IAB WAS NOT RETURNED TO DATASCOPE. EVENT COMPLICATIONS: MINOR ISCHEMIA/RENAL FAILURE - REPORTED 07/07/2000. PT'S CURRENT STATUS: EXPIRED - REPORTED 07/07/2000.

    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 0684-00-0255-01 4/23/02

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention