MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-04-19 for ALPINE INDUSTRIES * manufactured by Alpine Industries.
[16615843]
Rptr and spouse purchased an air purification unit mfg by alpine industries five years ago and have developed respiratory problems over the past two years which they have attributed to use of the device. Rptr believes that the unit puts levels of ozone and nitrous oxide into the air. The literature sold with the unit claims that it "kills bacteria and allergens in the air. " rptr also states that they have friends and family who have also used the unit and have developed respiratory illnesses such as asthma and bronchial infections. Rptr is planning on storing or destroying the device and accompanying literature but would like add'l contact from the fda before rptr proceeds.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4002985 |
| MDR Report Key | 328544 |
| Date Received | 2001-04-19 |
| Date of Report | 2001-03-14 |
| Date of Event | 1996-01-01 |
| Date Added to Maude | 2001-04-26 |
| 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 | ALPINE INDUSTRIES |
| Generic Name | AIR PURIFICATION UNIT |
| Product Code | FRF |
| Date Received | 2001-04-19 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 317937 |
| Manufacturer | ALPINE INDUSTRIES |
| Manufacturer Address | 9199 CENTRAL AVE NE BLAINE MN 554343422 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2001-04-19 |