MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2005-10-04 for manufactured by .
| Report Number | 2518436-2005-00001 |
| MDR Report Key | 698707 |
| Report Source | 06 |
| Date Received | 2005-10-04 |
| Date of Event | 2005-08-19 |
| Date Mfgr Received | 2005-08-27 |
| Date Added to Maude | 2006-04-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SUSAN MANTIA, MANAGER |
| Manufacturer Street | 2990 INDUSTRIAL BLVD. |
| Manufacturer City | BETHEL PARK PA 15102 |
| Manufacturer Country | US |
| Manufacturer Postal | 15102 |
| Manufacturer Phone | 4128541133 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Product Code | BXY |
| Date Received | 2005-10-04 |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 687788 |
| Baseline Brand Name | FLOW SELECTOR VALVE |
| Baseline Generic Name | O2 FLOW SELECTOR VALVE |
| Baseline Model No | SC 603-A |
| Baseline Catalog No | SC 603-A |
| Baseline ID | NA |
| Baseline Device Family | PRESSURE TUBING AND ACCESSORIES |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-10-04 |