MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-10-21 for PROZONE * manufactured by Bioteck Research.
[317841]
Pt purchased this device for a room (10'x 15'x 8') and thinks the ppb (parts per billion) exceed what is safe. Using ozone meter, ppb's ranged from 70-110 to 500 when close to machine. Pt has hx of mild asthma and had trouble breathing while in the room.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1029913 |
| MDR Report Key | 492736 |
| Date Received | 2003-10-21 |
| Date of Report | 2003-10-21 |
| Date of Event | 2003-10-08 |
| Date Added to Maude | 2003-11-03 |
| 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 | 3 |
| 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 | PROZONE |
| Generic Name | OZONE AIR, CLEANER |
| Product Code | FRF |
| Date Received | 2003-10-21 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | TRACKING# 140420932/FPRZ331/PG |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 481439 |
| Manufacturer | BIOTECK RESEARCH |
| Manufacturer Address | 7800 WHIPPLE AVENUE, NW CANTON OH 44767 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-10-21 |