BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT DL 9.5 FR. 40 CC. IAB

    MDR report key: 145053 · Received January 15, 1998

    Report

    Report Number
    2248146-1998-00002
    Event Type
    Malfunction
    Date Received
    January 15, 1998
    Report Date
    January 5, 1998
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: THE PRODUCT WAS NOT RETURNED TO DATASCOPE FOR EVALUATION INSPITE OF NUMEROUS ATTEMPTS TO CONTACT THE CUSTOMER FOR THE RETURN OF THE PRODUCT. THIS FOLLOW-UP MDR WAS MAILED TO THE FDA ON 10/13/98.

    Description of Event or Problem · 1

    EVENT: (CC# 98-00002) THE IAB LEAKED. THIS WAS THE ONLY INFORMATION AT THE TIME OF THE REPORT. INSPITE OF SEVERAL CALLS TO THE FACILITY, THE IAB WAS NEVER RETURNED TO DATASCOPE FOR EVALUATION. [EVENT COMPLICATIONS]: UNKNOWN - REPORTED 1/5/98. [PATIENT'S CURRENT STATUS]: UNK - RPT'D 1/5/98.

    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 CORP. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN