BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAT DL 9.5 FR. 34 CC. IAB

    MDR report key: 134989 · Received November 25, 1997

    Report

    Report Number
    2248146-1997-01296
    Event Type
    Injury
    Date Received
    November 25, 1997
    Date of Event
    October 14, 1997
    Report Date
    November 10, 1997
    Manufacturer
    DATASCOPE CORPORATION
    Product Code
    DSP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE IAB WAS INSERTED INTO THE PT ON 10/13/97 AT 9:00 A.M. AND REMOVED ON 10/14/97 AT 9:00 A.M. THE IAB DID NOT MALFUNCTION. A VASCULAR SURGEON WAS CONSULTED. REMOVAL WAS REQUIRED AND SURGEY WAS REQUIRED. ALSO, THE PT HAD A LARGE HEMATOMA AND REQUIRED SURGICAL EVACUATION. POST OP INFECTION REQ. DEBRIDEMENT AND IV ANTIBIOTICS. (EVENT COMPLICATIONS: REMOVAL REQUIRED/SURGERY/HEMATOMA/INFECTION) (PT'S CURRENT STATUS: UNK-RPT'D 11/10/97.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAT DL 9.5 FR. 34 CC. IAB INTRA-AORTIC BALLOON CATHETER DSP DATASCOPE CORPORATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Life Threatening| R