MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2007-05-01 for manufactured by .
[8042228]
Device passed our adsorbtion test criteria.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005724505-2007-00001 |
| MDR Report Key | 974409 |
| Report Source | 06 |
| Date Received | 2007-05-01 |
| Date Mfgr Received | 2007-04-02 |
| Device Manufacturer Date | 2006-09-01 |
| Date Added to Maude | 2008-01-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 3487 WEST 2100 SOUTH #100 |
| Manufacturer City | SALT LAKE CITY UT 84119 |
| Manufacturer Country | US |
| Manufacturer Postal | 84119 |
| Manufacturer Phone | 8019778877 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Product Code | BYW |
| Date Received | 2007-05-01 |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 942691 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-05-01 |