BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANDPIECE 1921002 HYDRODEBRIDER FRONTAL

    MDR report key: 3241262 · Received July 22, 2013

    Report

    Report Number
    1045254-2013-00467
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    June 28, 2013
    Report Date
    June 28, 2013
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    FQH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FENESTRATED ENDOSCOPIC SINUS SURGERY (FESS), THE PATIENT¿S EYE SWELLED UP. IT IS UNCLEAR AS TO WHAT CAUSED THE EVENT. THE PATIENT¿S POST-OPERATIVE OUTCOME WAS REPORTED TO BE GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341371 HANDPIECE 1921002 HYDRODEBRIDER FRONTAL LAVAGE, JET FQH MEDTRONIC XOMED, INC. 1921002 0206919157

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Other