BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAKRI TAMPONADE BALLOON CATHETER

    MDR report key: 7224122 · Received January 29, 2018

    Report

    Report Number
    1820334-2018-00301
    Event Type
    Malfunction
    Date Received
    January 29, 2018
    Date of Event
    March 17, 2016
    Report Date
    January 29, 2018
    Manufacturer
    COOK INC
    Product Code
    OQY
    UDI-DI
    10827002306735
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: COMMON DEVICE NAME: KNA. THIS MDR IS BEING FILED AFTER THE ASSOCIATED COMPLAINT WAS REVIEWED UNDER REMEDIATION PROTOCOL (B)(4), COMPLAINT/MDR RETROSPECTIVE REVIEW AND REMEDIATION AND REASSESSED AS REPORTABLE. ADDITIONAL COMPLAINT INVESTIGATION AND RECORD REMEDIATION WAS NOT PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON WAS LEAKING SALINE. ANOTHER BALLOON WAS USED TO CONTINUE THE PROCEDURE, AND THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67641 BAKRI TAMPONADE BALLOON CATHETER OQY COOK INC 10827002306735

    Patients

    Seq Age Sex Outcome Treatment
    1