MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-08-20 for LIVING AIR ELECTRONIC AIR-PURIFICATION OZONE GENERATOR XL-15S * manufactured by Living Air.
[183611]
Purchased the living air ionizer w/ozone made by alpine industries and 1 month later, both rptr's husband and herself were in the dr's office receiving intravenous prednisone due to lung spasms. Rptr has since developed lung problems which she never had and has to use inhalers. Rptr didn't realize it could be the machine until she read up on it. The lung problem rptr developed was emphysema. Rptr was sold the machine after she told them that her husband has asthma.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1017056 |
| MDR Report Key | 237559 |
| Date Received | 1999-08-20 |
| Date of Report | 1999-08-19 |
| Date of Event | 1999-01-18 |
| Date Added to Maude | 1999-08-31 |
| 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 |
| 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 ELECTRONIC AIR-PURIFICATION OZONE GENERATOR |
| Generic Name | AIR PURIFIER, OZONE GENERATOR |
| Product Code | FRF |
| Date Received | 1999-08-20 |
| Model Number | XL-15S |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 230211 |
| Manufacturer | LIVING AIR |
| Manufacturer Address | 310 T. ELMER COX DR. GREENEVILLE TN 37743 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1999-08-20 |