BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALLOON SEEKER

    MDR report key: 4013687 · Received August 15, 2014

    Report

    Report Number
    1045254-2014-00190
    Event Type
    Injury
    Date Received
    August 15, 2014
    Date of Event
    July 23, 2014
    Report Date
    July 23, 2014
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    LRC
    PMA / PMN Number
    K132297
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONCOMITANT DEVICE: 18INFKIT ¿ INFLATOR BALLOON 18INFKIT, LOT # 0208473513, MANUFACTURE DATE: JUNE 23, 2014, EXPIRATION DATE: DECEMBER 15, 2016, 510(K): K132297. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE SURGEON DILATED ONE MAXILLARY SINUS AND IT WAS FINE. AS SHE DILATED THE OTHER MAXILLARY SINUS THERE WAS AN ORBITAL FRACTURE. MEDICAL INTERVENTION WAS NOT NEEDED AS A RESULT OF THIS FRACTURE. THE INTENDED SURGERY WAS COMPLETED AND THE PATIENT IS OKAY. SHE RECEIVED SOME MINOR BLACK-EYE AND BRUISING BECAUSE OF THE FRACTURE AND WAS TOLD TO ¿ICE AND REST.¿ THE SALES REP WAS NOT IN THE CASE, BUT IN COMMUNICATIONS WITH THE DOCTOR, LEARNED THAT THE PATIENT'S ANATOMY WAS CONSIDERED VERY SMALL. THE DOCTOR THINKS THE BALLOON SIZE WAS TOO BIG, AND THAT SHE MIGHT NOT HAVE APPLIED ENOUGH LATERAL PRESSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489274 BALLOON SEEKER INSTRUMENT, ENT MANUAL SURGICAL LRC MEDTRONIC XOMED INC. 1830707MAX 0208515699

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Other