BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK® CERVICAL RIPENING BALLOON

    MDR report key: 5802373 · Received July 18, 2016

    Report

    Report Number
    1820334-2016-00731
    Event Type
    Malfunction
    Date Received
    July 18, 2016
    Date of Event
    June 22, 2016
    Report Date
    June 28, 2017
    Manufacturer
    COOK INC
    Product Code
    PFJ
    UDI-DI
    00827002481497
    PMA / PMN Number
    K131206
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510(K): K131206. EVENT IS STILL UNDER INVESTIGATION AT THIS TIME.

    Additional Manufacturer Narrative · 1

    ONE COMPLAINT DEVICE WAS RETURNED FOR INVESTIGATION. THE CHECK IN PHOTOS SHOW A SPLIT IN THE BALLOON. A SEARCH OF THE MANUFACTURER'S DATABASE IDENTIFIED THIS COMPLAINT TO BE ONE OF TWO COMPLAINTS ASSOCIATED WITH LOT 5813666.

    Description of Event or Problem · 1

    THE INITIAL INFORMATION PROVIDED STATED THAT THE BALLOON WAS BROKEN AND LEAKING WHEN INJECTING 20ML SALINE. UPON RECEIPT OF THE PRODUCT, IT WAS NOTED THE BALLOON HAD RUPTURED IN A CIRCUMFERENTIAL DIRECTION. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455356 COOK® CERVICAL RIPENING BALLOON PFJ, DILATOR, CERVICAL, HYGROSCOPIC-IAMINARIA PFJ COOK INC N/A 00827002481497

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other