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 |