MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-06-01 for LIVING AIR XL-15 CLASSIC XL15 CLASSIC NA manufactured by Alpine Industries, Inc..
[222093]
Complainant purchased three ozone air purifiers, model no xl-15 classic within the past year for personal use. Complainant purchased the equipment after seeing the product in use at a client's residence. Complainant stated that two of the three purifiers needed repair in the last few months and the complainant sent them back to the mfr for repair under the warranty. The complainant was told by a friend that the living air ozone air purifier was banned in the state and the complainant was concerned that they were exposing their family to something hazardous, so they contacted the state dept of health and were referred to the fda.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4003028 |
| MDR Report Key | 341700 |
| Date Received | 2001-06-01 |
| Date of Report | 2001-06-01 |
| Date Added to Maude | 2001-07-16 |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIVING AIR XL-15 CLASSIC |
| Generic Name | OZONE AIR PURIFIER |
| Product Code | FRA |
| Date Received | 2001-06-01 |
| Model Number | XL15 CLASSIC |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 331036 |
| Manufacturer | ALPINE INDUSTRIES, INC. |
| Manufacturer Address | 310 T ELMER COX DR GREENVILLE TN 37745 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2001-06-01 |