MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-01-25 for AIR CARE UV R-18D manufactured by Air Care Uv.
[3223598]
Company claimed on their website that their device will prevent asthma attacks, but it has not helped and i can not find any info about this item being approved by the fda at all on their website: (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5028749 |
| MDR Report Key | 2932856 |
| Date Received | 2013-01-25 |
| Date of Report | 2013-01-16 |
| Date of Event | 2013-01-06 |
| Date Added to Maude | 2013-01-30 |
| 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 | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AIR CARE UV R-18D |
| Generic Name | UVC RADIATION AIR STERILIZER |
| Product Code | FRF |
| Date Received | 2013-01-25 |
| Model Number | R-18D |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AIR CARE UV |
| Manufacturer Address | 4111 N 42ND TERRACE HOLLYWOOD FL 33021 US 33021 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-01-25 |