MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-04-15 for PROSORBA 9007031 * manufactured by Fresenius Hemocare, Inc..
[15484856]
Patient with worsening anemia, presumably from bleeding gastric ulcer. By treatment #3 patient's "h/h" had dropped to 9. 9/29. 9. After this treatment patient's speech became slurred and patient developed left hemiparesis. Diagnosed with cerebrovascular accident and discharged after 5 days with symptoms resolving. This event occurred in 2000 but was not reported. It was "mentioned" to a sales rep 9 months later, confirmed by physician the next month.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 3032792-2002-00003 |
MDR Report Key | 388697 |
Date Received | 2002-04-15 |
Date of Report | 2002-04-12 |
Date of Event | 2000-03-01 |
Date Facility Aware | 2001-01-04 |
Device Manufacturer Date | 1999-08-01 |
Date Added to Maude | 2002-04-19 |
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 | 3 |
Manufacturer Contact | TOM TROTTER |
Manufacturer Street | 6675 - 185TH AVE. NE SUITE 100 |
Manufacturer City | REDMOND WA 98052 |
Manufacturer Country | US |
Manufacturer Postal | 98052 |
Manufacturer Phone | 4254971197 |
Manufacturer G1 | * |
Manufacturer Street | * |
Manufacturer City | * |
Manufacturer Country | * |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | PROSORBA |
Generic Name | IMMUNOADSORPTION COLUMN |
Product Code | FLD |
Date Received | 2002-04-15 |
Model Number | 9007031 |
Catalog Number | * |
Lot Number | 081899H |
ID Number | PMA P850020 |
Device Expiration Date | 2000-08-18 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | N |
Implant Flag | N |
Date Removed | U |
Device Sequence No | 1 |
Device Event Key | 377746 |
Manufacturer | FRESENIUS HEMOCARE, INC. |
Manufacturer Address | 6675 - 185TH AVE. NE SUITE 100 REDMOND WA 98052 US |
Baseline Brand Name | PROSORBA |
Baseline Generic Name | IMMUNOADSORPTION COLUMN |
Baseline Model No | 9007031 |
Baseline Catalog No | * |
Baseline ID | PMA P850020 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Hospitalization | 2002-04-15 |