BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS

    MDR report key: 25164332 · Received May 13, 2026

    Report

    Report Number
    1820334-2026-00511
    Event Type
    Malfunction
    Date Received
    May 13, 2026
    Date of Event
    February 2, 2026
    Report Date
    May 13, 2026
    Manufacturer
    COOK INC
    Product Code
    OQY
    UDI-DI
    00827002242371
    PMA / PMN Number
    K170622
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1 - PHONE NUMBER: (B)(6) H3 - DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SECOND BALLOON OF A COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS LEAKED DURING A POST PARTUM HEMORRHAGE PROCEDURE. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. AT THIS TIME, NO ADVERSE EFFECTS OR ADDITIONAL PROCEDURES FOR THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE. THE FIRST REPORTED BALLOON THAT LEAKED IS REPORTED UNDER THE MANUFACTURER REPORT NUMBER 100695/1820334-2026-00463.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120168 COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS OQY, INTRAUTERINE TAMPONADE BALLOON OQY COOK INC G24237 16199175 00827002242371

    Patients

    Seq Age Sex Outcome Treatment
    1