MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-03-18 for EDENPURE G7 YD700 manufactured by Sci Resources Partners.
[17472635]
Plug in air purifier -edenpure- "gave gas vapors that makes me nausea & a headache. " dates of use. 2008. Diagnosis or reason for use: purify air. Event reappeared after reintroduction: yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5005911 |
| MDR Report Key | 1015784 |
| Date Received | 2008-03-18 |
| Date of Report | 2008-03-18 |
| Date of Event | 2008-03-18 |
| Date Added to Maude | 2008-03-27 |
| 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 | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EDENPURE G7 |
| Generic Name | NONE |
| Product Code | FRF |
| Date Received | 2008-03-18 |
| Model Number | YD700 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 985415 |
| Manufacturer | SCI RESOURCES PARTNERS |
| Manufacturer Address | 7800 WHIPPLE AVE. NORTH WEST NORTH CANTON OH 447206928 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-03-18 |