MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2006-03-30 for manufactured by .
| Report Number | 9616240-2006-00262 |
| MDR Report Key | 697495 |
| Report Source | 05,06,07 |
| Date Received | 2006-03-30 |
| Date of Event | 2006-02-27 |
| Date Mfgr Received | 2006-02-28 |
| Device Manufacturer Date | 2003-04-01 |
| Date Added to Maude | 2006-04-11 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | FRANCESCO BARDELLI |
| Manufacturer Street | VIA MODENESE, 66 |
| Manufacturer City | MEDOLLA (MO) I-41036 |
| Manufacturer Country | IT |
| Manufacturer Postal | I-41036 |
| Manufacturer Phone | 53550111 |
| Manufacturer G1 | GAMBRO DASCO |
| Manufacturer Street | VIA MODENESE, 66 |
| Manufacturer City | MEDOLLA (MO) I-41036 |
| Manufacturer Country | IT |
| Manufacturer Postal Code | I-41036 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Product Code | FIF |
| Date Received | 2006-03-30 |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 683750 |
| Baseline Brand Name | PRISMA CONTROL UNIT |
| Baseline Generic Name | INTENSIVE CARE HEMODIALYSIS |
| Baseline Model No | PRISMA |
| Baseline Catalog No | 018080100 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-03-30 |