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 distributor report with the FDA on 2020-02-17 for AIRCAST VENAPRO SYSTEM 30M manufactured by Innovamed Health, Llc.

Event Text Entries

[183327796] No device was returned for evaluation. If the device is received, a follow-up report will be submitted upon completion of product evaluation.
Patient Sequence No: 1, Text Type: N, H10


[183327797] It was reported that the venapro system was overheating during treatment. There was no reported patient harm.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005844491-2020-00004
MDR Report Key9716535
Report SourceDISTRIBUTOR
Date Received2020-02-17
Date of Report2020-02-16
Date of Event2020-02-06
Date Mfgr Received2020-02-06
Date Added to Maude2020-02-17
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactBRIAN BECKER
Manufacturer Street2900 LAKE VISTA DRIVE
Manufacturer CityLEWISVILLE, TX
Manufacturer CountryUS
Manufacturer G1INNOVAMED HEALTH, LLC
Manufacturer Street2441 S. 1560 WEST
Manufacturer CityWOODS CROSS, UT
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAIRCAST VENAPRO SYSTEM
Generic NameSLEEVE, LIMB, COMPRESSIBLE
Product CodeJOW
Date Received2020-02-17
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 US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-17

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