BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 188348 · Received September 16, 1998

    Report

    Report Number
    2248146-1998-01045
    Event Type
    Malfunction
    Date Received
    September 16, 1998
    Date of Event
    September 6, 1998
    Manufacturer
    *
    Product Code
    DSP
    Report Source
    Manufacturer report

    Narratives

    Description of Event or Problem · 1

    EVENT: (CC# 98-1120) AT 0230 ON 9/6/98, THE NURSING STAFF BECAME AWARE THAT THE IAB HAD LEAKED. THE SURGEON WAS NOTIFIED AND ARRIVED AT THE HOSPITAL SOME TIME BETWEEN 3:00 AND 3:30 TO REMOVE THE IAB. THE PATIENT IS DOING FINE WITHOUT IAB SUPPORT. (ON 9/10/98, DATASCOPE ALSO RECEIVED THE MANDATORY MEDWATCH FORM FROM THE DISTRIBUTOR; UF/DIST REPORT NUMBER: FDA-34955-1998-009). ON 3/15/99, DATASCOPE WAS NOTIFIED THAT THE IAB WAS PROBABLY DISCARDED AND WOULD NOT BE RETURNED FOR EVALUATION. [EVENT COMPLICATIONS]: NONE FROM THE EVENT - REPORTED 9/10/98. [PATIENT'S CURRENT STATUS]: FINE - RPT'D 9/10/98.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * * DSP * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *