BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIRCAST VENAPRO SYSTEM

    MDR report key: 8659182 · Received May 31, 2019

    Report

    Report Number
    3005844491-2019-00001
    Event Type
    Injury
    Date Received
    May 31, 2019
    Date of Event
    May 9, 2019
    Report Date
    May 31, 2019
    Manufacturer
    INNOVAMED HEALTH, LLC
    Product Code
    JOW
    PMA / PMN Number
    K133274
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATED BY MFR: ONE VENAPRO SYSTEM WAS RETURNED FOR EVALUATION. THERE WAS NO APPARENT EVIDENCE OF HEAT DAMAGE. THE CHARGER AND PUMPS WERE TESTED FOR OVER 17 HOURS. THE PUMPS WERE TESTED ON BATTERY FOR OVER EIGHT HOURS AND TESTED WHILE PLUGGED IN FOR OVER EIGHT HOURS. NO HEAT WAS OBSERVED. PER EXEMPTION NUMBER E2015057.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BATTERY OF A VENAPRO UNIT BECAME HOT AND BURNED A PATIENT. A PHOTO PROVIDED IN ASSOCIATION WITH THE EVENT PRESENTS A LARGE BLISTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453457 AIRCAST VENAPRO SYSTEM SLEEVE, LIMB, COMPRESSIBLE JOW INNOVAMED HEALTH, LLC 30M

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention