BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRCAST

    MDR report key: 6564550 · Received May 12, 2017

    Report

    Report Number
    3005844491-2017-00002
    Event Type
    Malfunction
    Date Received
    May 12, 2017
    Date of Event
    May 2, 2017
    Report Date
    May 12, 2017
    Manufacturer
    INNOVAMED HEALTH LLC
    Product Code
    JOW
    PMA / PMN Number
    K133274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PER EXEMPTION E2015057. (B)(4).

    Description of Event or Problem · 0

    COMPLAINT RECEIVED THAT ALLEGES "30M MELTED, PUMP GOT HOT". QUESTIONNAIRE NOT RECEIVED FROM CUSTOMER OR CLINICIAN. DEVICE NOT RETURNED TO MANUFACTURER FOR EVALUATION. NO INDICATION EVENT CAUSED OR CONTRIBUTED TO SERIOUS INJURY, PERMANENT IMPAIRMENT OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345427 AIRCAST VENAPRO SYSTEM JOW INNOVAMED HEALTH LLC 30M

    Patients

    Seq Age Sex Outcome Treatment
    1 Other