MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-12-22 for PROSORBA COLUMN 9798701 manufactured by Fresenius Hemocare.
[20021768]
Pt developed "altered mental status" with inappropriate speech, after 2nd prosorba treatment. Wbc and platelets within normal limits. Blood cultures negative. Ua with 2+ bacteria so treated for uti. Ct negative, however mri showed "multiple infarcts. " subequently a dvt was diagnosed in her superficial femoral vein. Antibiotics and heparin administered. Pt discharged with much improved mental status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3032792-2005-00025 |
| MDR Report Key | 657207 |
| Date Received | 2005-12-22 |
| Date of Report | 2005-12-22 |
| Date of Event | 2005-12-04 |
| Report Date | 2005-12-22 |
| Date Reported to Mfgr | 2005-12-05 |
| Date Mfgr Received | 2005-12-05 |
| Device Manufacturer Date | 2005-04-01 |
| Date Added to Maude | 2005-12-30 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JOSHUA LASKER |
| Manufacturer Street | 14715 BE 95TH ST, STE 100 |
| Manufacturer City | REDMOND WA 98052 |
| Manufacturer Country | US |
| Manufacturer Postal | 98052 |
| Manufacturer Phone | 4252422065 |
| 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 COLUMN |
| Generic Name | IMMUOADSORPTION COLUMN |
| Product Code | LQQ |
| Date Received | 2005-12-22 |
| Model Number | 9798701 |
| Catalog Number | 9798701 |
| Lot Number | RON001D |
| ID Number | NA |
| Device Expiration Date | 2005-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 7 MO |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 646695 |
| Manufacturer | FRESENIUS HEMOCARE |
| Manufacturer Address | * REDMOND WA * US |
| Baseline Brand Name | PROSORBA COLUMN |
| Baseline Generic Name | THERAPEUTIC PLASMA EXCHA |
| Baseline Catalog No | 9798701 |
| Baseline Device Family | PROTEIN A IMMUNOADSORPTION COL |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 12 |
| Baseline PMA Flag | Y |
| Premarket Approval | P8500 |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2005-12-22 |