BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRA-AORTIC BALLOON CATHETER

    MDR report key: 184719 · Received August 27, 1998

    Report

    Report Number
    2248146-1998-00958
    Event Type
    Malfunction
    Date Received
    August 27, 1998
    Report Date
    August 14, 1998
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    EVENT: (CC# 98-01015) THE IAB LEAKED. THIS WAS THE ONLY INFORMATION AT THE TIME OF THE REPORT. ON 1/21/99, DATASCOPE WAS NOTIFIED THAT THE IAB WAS DISCARDED AND WOULD NOT BE RETURNED FOR EVALUATION. [EVENT COMPLICATIONS]: UNKNOWN - REPORTED 8/14/98. [PATIENT'S CURRENT STATUS]: UNK - RPT'D 8/14/98.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN