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.
[183328785]
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
[183328786]
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
| Report Number | 3005844491-2020-00003 |
| MDR Report Key | 9716534 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-02-17 |
| Date of Report | 2020-02-16 |
| Date of Event | 2020-02-06 |
| Date Mfgr Received | 2020-02-06 |
| Date Added to Maude | 2020-02-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BRIAN BECKER |
| Manufacturer Street | 2900 LAKE VISTA DRIVE |
| Manufacturer City | LEWISVILLE, TX |
| Manufacturer Country | US |
| Manufacturer G1 | INNOVAMED HEALTH, LLC |
| Manufacturer Street | 2441 S. 1560 WEST |
| Manufacturer City | WOODS CROSS, UT |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AIRCAST VENAPRO SYSTEM |
| Generic Name | SLEEVE, LIMB, COMPRESSIBLE |
| Product Code | JOW |
| Date Received | 2020-02-17 |
| Model Number | 30M |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INNOVAMED HEALTH, LLC |
| Manufacturer Address | 2441 S. 1560 WEST WOODS CROSS, UT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-17 |