BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALLOON CONTROL UNIT

    MDR report key: 3962585 · Received July 14, 2014

    Report

    Report Number
    2951238-2014-00280
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 19, 2014
    Manufacturer
    OLYMPUS MED SYSTEM CORP
    Product Code
    KOG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT HAS BEEN RETURNED TO OLYMPUS FOR EVALUATION. HOWEVER, THE EVALUATION HAS NOT BEEN COMPLETED. UPON COMPLETION OF THE EVALUATION, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE, THE PATIENT SUSTAINED AN UNIDENTIFIED INJURY. NO FURTHER INFORMATION PROVIDED. OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT, BUT WITH NO RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409072 BALLOON CONTROL UNIT BALLOON CONTROL UNIT KOG OLYMPUS MED SYSTEM CORP OBCU NA

    Patients

    Seq Age Sex Outcome Treatment
    1