MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-07-31 for SHARPER IMAGE UNK manufactured by Sharper Image.
[245289]
Purifier uses the principle of ionization and it creates ozone. 100 ppbillion of ozone was measured and rptr thinks this is too much. Concerns related to store mgr. Rptr believes device is unsafe.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1022501 |
| MDR Report Key | 344191 |
| Date Received | 2001-07-31 |
| Date of Report | 2001-07-31 |
| Date of Event | 2001-07-30 |
| Date Added to Maude | 2001-08-01 |
| 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 | SHARPER IMAGE |
| Generic Name | AIR PURIFIER/IONIZER |
| Product Code | FRF |
| Date Received | 2001-07-31 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | NA |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 333520 |
| Manufacturer | SHARPER IMAGE |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2001-07-31 |