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 2003-10-22 for * manufactured by Medtronic Perfusion Systems.
Report Number | 2184009-2003-00066 |
MDR Report Key | 491891 |
Report Source | 05,06,07 |
Date Received | 2003-10-22 |
Date of Event | 2003-01-01 |
Date Mfgr Received | 2003-09-25 |
Date Added to Maude | 2003-10-29 |
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 | 0 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 0 |
Manufacturer Contact | LISA WEIK |
Manufacturer Street | 8299 CENTRAL AVE NE |
Manufacturer City | MINNEAPOLIS MN 55432 |
Manufacturer Country | US |
Manufacturer Postal | 55432 |
Manufacturer Phone | 7635146694 |
Manufacturer G1 | MEDTRONIC PERFUSION SYSTEMS |
Manufacturer Street | 7611 NORTHLAND DR |
Manufacturer City | BRROKLYN PARK MN 55428 |
Manufacturer Country | US |
Manufacturer Postal Code | 55428 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | * |
Generic Name | * |
Product Code | DXS |
Date Received | 2003-10-22 |
Model Number | * |
Catalog Number | * |
Lot Number | * |
ID Number | * |
Device Availability | N |
Device Eval'ed by Mfgr | R |
Implant Flag | N |
Date Removed | * |
Device Sequence No | 1 |
Device Event Key | 480591 |
Manufacturer | MEDTRONIC PERFUSION SYSTEMS |
Manufacturer Address | 7611 NORTHLAND DR. MINNEAPOLIS MN 55428 US |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2003-10-22 |