MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2005-09-27 for * 0500316E manufactured by Ogden Manufacturing.
| Report Number | 1713747-2005-00041 |
| MDR Report Key | 638136 |
| Report Source | 05,06 |
| Date Received | 2005-09-27 |
| Date of Report | 2005-09-26 |
| Date of Event | 2005-08-22 |
| Date Mfgr Received | 2005-09-07 |
| Device Manufacturer Date | 2005-01-01 |
| Date Added to Maude | 2005-09-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | ELIZABETH POLHEMUS |
| Manufacturer Street | TWO LEDGEMONT CENTER |
| Manufacturer City | LEXINGTON MA 02173 |
| Manufacturer Country | US |
| Manufacturer Postal | 02173 |
| Manufacturer Phone | 7814029075 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | * |
| Product Code | FJY |
| Date Received | 2005-09-27 |
| Model Number | NA |
| Catalog Number | 0500316E |
| Lot Number | 5AU320 |
| ID Number | NA |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 627663 |
| Manufacturer | OGDEN MANUFACTURING |
| Manufacturer Address | * * * |
| Baseline Brand Name | OPTIFLUX 160NRE DIALYZER FINISHED ASSY. |
| Baseline Generic Name | DIALYZER |
| Baseline Model No | NA |
| Baseline Catalog No | 0500316E |
| Baseline ID | 0500316E |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-09-27 |