BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 6167853 · Received December 12, 2016

    Report

    Report Number
    3005172759-2016-00016
    Event Type
    Malfunction
    Date Received
    December 12, 2016
    Report Date
    October 30, 2015
    Manufacturer
    ACCLARENT, INC.
    Product Code
    LRC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE AGE OF THE PATIENT IS NOT KNOWN. THE LOT HISTORY RECORD REVIEW COULD BE PERFORMED AS LOT NUMBER FOR THE SUBJECT DEVICE WAS UNAVAILABLE.

    Description of Event or Problem · 1

    ACCLARENT WAS INFORMED ON 10/30/2015, OF AN EVENT THAT OCCURRED ON AN UNKNOWN DATE INVOLVING AN UNKNOWN TYPE OF ACCLARENT BALLOON. THE REPORTED EVENT WAS THAT THE BALLOON DID NOT DEFLATE. THE PHYSICIAN ADVISED THAT HE NEEDED FORCEPS TO MANUALLY EXCISE THE BALLOON FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819353 UNKNOWN UNKNOWN LRC ACCLARENT, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1