MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2004-12-27 for PROSORBA COLUMN 9798701 manufactured by Fresenius Hemocare.
[20512435]
Prosorba pt diagnosed with pulmonary embolism. They had received their 5th treatment in nov. 2004 then cancelled their treatment the following week due to a "pulled muscle" in their side. Approximately 2 days later they was diagnosed with a pulmonary embolism. Co have been unable to obtain any further detail on this diagnosis. They were hospitalized and anticoagulated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3032792-2004-00010 |
| MDR Report Key | 562381 |
| Report Source | 05 |
| Date Received | 2004-12-27 |
| Date of Report | 2004-12-27 |
| Date of Event | 2004-11-10 |
| Date Facility Aware | 2004-11-30 |
| Report Date | 2004-12-27 |
| Date Mfgr Received | 2004-11-30 |
| Device Manufacturer Date | 2004-03-01 |
| Date Added to Maude | 2005-01-03 |
| 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 | KAREN QUARFORD |
| Manufacturer Street | 14715 NE 95 ST, SUITE 100 |
| Manufacturer City | REDMOND WA 98052 |
| Manufacturer Country | US |
| Manufacturer Postal | 98052 |
| Manufacturer Phone | 4252422000 |
| Manufacturer G1 | FRESENIUS HEMOCARE, INC. |
| Manufacturer Street | 14715 NE 95TH ST, SUITE 100 |
| Manufacturer City | REDMOND WA 98052 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 98052 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROSORBA COLUMN |
| Generic Name | PROSORBA COLUMN |
| Product Code | LQQ |
| Date Received | 2004-12-27 |
| Model Number | 9798701 |
| Catalog Number | 9798701 |
| Lot Number | QCN002F |
| ID Number | * |
| Device Expiration Date | 2004-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | 1.5 YR |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 552099 |
| Manufacturer | FRESENIUS HEMOCARE |
| Manufacturer Address | 14715 NE 95TH ST. REDMOND WA 98052 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. Hospitalization | 2004-12-27 |