AIRCAST VENAPRO SYSTEM 30M

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-10-25 for AIRCAST VENAPRO SYSTEM 30M manufactured by Innovamed Health, Llc.

MAUDE Entry Details

Report Number3005844491-2019-00020
MDR Report Key9240454
Report SourceCONSUMER
Date Received2019-10-25
Date of Report2019-10-25
Date of Event2019-10-01
Date Mfgr Received2019-10-02
Date Added to Maude2019-10-25
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Manufacturer ContactMR. BRIAN BECKER
Manufacturer Street2900 LAKE VISTA DRIVE
Manufacturer CityLEWISVILLE TX 75067
Manufacturer CountryUS
Manufacturer Postal75067
Manufacturer G1INNOVAMED HEALTH, LLC
Manufacturer Street2441 S. 1560 WEST
Manufacturer CityWOODS CROSS UT 84087
Manufacturer CountryUS
Manufacturer Postal Code84087
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAIRCAST VENAPRO SYSTEM
Generic NameSLEEVE, LIMB, COMPRESSIBLE
Product CodeJOW
Date Received2019-10-25
Model Number30M
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerINNOVAMED HEALTH, LLC
Manufacturer Address2441 S. 1560 WEST WOODS CROSS UT 84087 US 84087


Patients

Patient NumberTreatmentOutcomeDate
10 2019-10-25

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.