BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EBB COMPLETE TAMPONADE SYSTEM

    MDR report key: 9946644 · Received April 9, 2020

    Report

    Report Number
    1722684-2020-00005
    Event Type
    Injury
    Date Received
    April 9, 2020
    Date of Event
    February 7, 2020
    Report Date
    April 6, 2020
    Manufacturer
    CLINICAL INNOVATIONS, LLC
    Product Code
    OQY
    UDI-DI
    00814247020765
    PMA / PMN Number
    K153591
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PPH OR BLEEDING IS FRAUGHT WITH POTENTIAL COMPLICATIONS AND AN INJURY IS ALWAYS A RISK IN THIS SITUATION. THE PATIENT HAD TO UNDERGO A HYSTERECTOMY DUE TO THE UTERINE BALLOON FAILURE AFTER THE PHYSICIAN PRESSED THE BALLOON WITH HIS FINGERS AFTER PLACEMENT. CLINICAL INNOVATIONS DOES NOT RECOMMEND PRESSING THE BALLOON AFTER CORRECT PLACEMENT HAS BEEN VERIFIED.

    Description of Event or Problem · 1

    THE EBB WAS USED ON A PATIENT AFTER A MISCARRIAGE IN THE FIRST TRIMESTER OF PREGNANCY. THE PHYSICIAN USED THE EBB IN ORDER TO STOP THE PATIENT'S BLEEDING AFTER THE MISCARRIAGE AND TO AVOID A HYSTERECTOMY. THE EBB BALLOON BURST AFTER THE PHYSICIAN PRESSED HIS FINGERS AGAINST IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409855 EBB COMPLETE TAMPONADE SYSTEM INTRAUTERINE TAMPONADE BALLOON OQY CLINICAL INNOVATIONS, LLC CTS-1000 191284 00814247020765

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention