MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-03 for AIRLIFE VYAIRE INCENTIVE SPIROMETER 001902A manufactured by Vyaire Medical, Inc..
Report Number | MW5089543 |
MDR Report Key | 8961095 |
Date Received | 2019-09-03 |
Date Added to Maude | 2019-09-04 |
Event Key | 0 |
Report Source Code | Voluntary report |
Manufacturer Link | N |
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 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 0 |
Brand Name | AIRLIFE VYAIRE INCENTIVE SPIROMETER |
Generic Name | SPIROMETER, THERAPEUTIC (INCENTIVE) |
Product Code | BWF |
Date Received | 2019-09-03 |
Model Number | 001902A |
Lot Number | CM18S27 |
Device Availability | * |
Device Eval'ed by Mfgr | I |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | VYAIRE MEDICAL, INC. |
Manufacturer Address | METTAWA IL 60045 US 60045 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 2019-09-03 |