BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNA INSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGIC

    MDR report key: 5756170 · Received June 28, 2016

    Report

    Report Number
    1820334-2016-00566
    Event Type
    Malfunction
    Date Received
    June 28, 2016
    Date of Event
    June 2, 2016
    Report Date
    June 29, 2017
    Manufacturer
    COOK INC
    Product Code
    KNA
    UDI-DI
    10827002242378
    PMA / PMN Number
    K062438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COOK (B)(4) POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS. (B)(4). EVENT IS STILL UNDER INVESTIGATION AT THIS TIME.

    Additional Manufacturer Narrative · 1

    INSTRUCTIONS FOR USE (IFU) J-SOSR_REV1 IN ORDER TO MAXIMIZE THE TAMPONADE EFFECT, CONSTANT PRESSURE MUST BE EFFECTED BETWEEN THE BALLOON WALL AND THE TISSUE SERVICE. PRESSURE CAN BE ACHIEVED AND MAINTAINED BY APPLYING GENTLE TRACTION TO THE BALLOON SHAFT, BEFORE SECURING TO THE PATIENT'S LEG, OR ATTACHING WEIGHT NOT TO EXCEED 500 GRAMS. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO NON-CONFORMANCES WERE NOTED. A QUERY OF THE MANUFACTURER'S DATABASE IDENTIFIED THIS COMPLAINT TO BE ONE OF TWO COMPLAINTS ASSOCIATED WITH COMPLAINT LOT NUMBER 6429287.

    Description of Event or Problem · 1

    THE FEMALE PATIENT EXPERIENCED POSTPARTUM HEMORRHAGE. THE BALLOON WAS PLACED AND THE USER WAS ABLE TO FILL THE BALLOON AND COMPLETE THE PROCEDURE. HOWEVER, THE BALLOON KEPT SLIPPING OUT. THE PATIENT WAS TAKEN TO SURGERY FOR A HYSTERECTOMY PROCEDURE. ADDITIONAL INFORMATION WAS PROVIDED ON 10JUNE2016: THE SURGERY WAS NOT DUE TO THE PRODUCT MALFUNCTION. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411116 KNA INSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGIC KNA COOK INC N/A 10827002242378

    Patients

    Seq Age Sex Outcome Treatment
    1