BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK

    MDR report key: 703786 · Received April 20, 2006

    Report

    Report Number
    2248146-2006-00094
    Event Type
    Malfunction
    Date Received
    April 20, 2006
    Report Date
    April 20, 2006
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AN 8FR FIDELTY USER CARTON WAS RETURNED; VISUAL EXAMINATION OF THE CONTENTS REVEALED TWO SEALED INSERTION KITS; PACKAGED ON TOP WAS AN 8FR FIDELITY INSERTION KIT, LOT NUMBER: GAS, EXPIRATION DATE:2009/12/11. PACKAGED BELOW WAS AN 8 FR PROFILE INSERTION KIT, LOT NUMBER: BPE, EXPIRATION DATE 2002-09-23. NO IAB WAS FOUND IN THE CARTON. EXPIRATION DATE: 2006-12-04.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK INTRA-AORTIC BALLOON DSP DATASCOPE CORP. UNK *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN