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 |