MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-04-30 for LIVING AIR XL-15 * manufactured by Alpine Industries.
[141161]
Rptr purchased the product with intent to eliminate mold in her home. At that time, she was ensured by the co rep that the device was not harmful. The rptr was dissatisfied with the product's ability to remove mold. The rptr was also in contact with the american lung association and the epa, who both informed the rptr that the device "produces ozone", and shouldn't be used by someone with lung problems. While the device was in use, the rptr developed pneumonia with serious episodes of shortness of breath for 6 weeks. The rptr contacted the mfr, however she states that they will not collect the device or refund the purchase amount of 600. 00.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1016226 |
| MDR Report Key | 221455 |
| Date Received | 1999-04-30 |
| Date of Report | 1999-04-30 |
| Date of Event | 1999-02-01 |
| Date Added to Maude | 1999-05-05 |
| 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 |
| Generic Name | AIR PURIFICATION SYSTEM |
| Product Code | FRF |
| Date Received | 1999-04-30 |
| Model Number | XL-15 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 214748 |
| Manufacturer | ALPINE INDUSTRIES |
| Manufacturer Address | 310 ELMER COX GREENVILLE TN 37744 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1999-04-30 |