BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EBB COMPLETE TAMPONADE SYSTEM

    MDR report key: 4445167 · Received December 29, 2014

    Report

    Report Number
    1722684-2014-00003
    Event Type
    Malfunction
    Date Received
    December 29, 2014
    Date of Event
    December 11, 2014
    Report Date
    December 24, 2014
    Manufacturer
    CLINICAL INNOVATIONS, LLC
    Product Code
    OQY
    PMA / PMN Number
    K091958
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER DISCUSSIONS WITH PHYSICIAN CONFIRMED THAT PATIENT STABILIZED WITH MEDICATION. DEVICES RETURNED, COMPLAINT CONDITION CONFIRMED. BALLOON MATERIAL SEPARATED FROM DEVICE. DEVICE FROM PREVIOUSLY UNREPORTED FAILURE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    TWO SEPARATE DEVICES FAILED ON SAME PATIENT. REPORT ALSO INCLUDED A PREVIOUSLY UNREPORTED FAILURE THAT HAD OCCURRED APPROXIMATELY THREE WEEKS PRIOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855074 EBB COMPLETE TAMPONADE SYSTEM EBB COMPLETE TAMPONADE SYSTEM OQY CLINICAL INNOVATIONS, LLC 0814-F-108

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK