MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-09-29 for PROSORBA COLUMN 9798701 manufactured by Fresenius Hemocare.
[19891502]
A female ra patient admitted to hospital the evening after her first prosorba treatment with abdominal pain and fever. Diagnostic workup did not find cause. Symptoms resolved and patient discharged. Her physician feels it was some kind of immune response to prosorba, possibly, because she did not take any premedication. The patient has resumed prosorba treatment with premed of tylenol, benadryl and solu-cortef and tolerated it well.
Patient Sequence No: 1, Text Type: D, B5
[19936282]
This investigation is a clinical investigation only. Return of product not requested as evaluation of device after use not relevant to reported event. The device was used according to labeled indications and in the appropriate environment. Temporal relationship of the event and prosorba would suggest a contributory relationship.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3032792-2006-00013 |
| MDR Report Key | 766993 |
| Report Source | 05 |
| Date Received | 2006-09-29 |
| Date of Report | 2006-09-29 |
| Date of Event | 2006-08-29 |
| Report Date | 2006-09-28 |
| Date Mfgr Received | 2006-08-29 |
| Device Manufacturer Date | 2005-07-01 |
| Date Added to Maude | 2006-10-06 |
| 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 N.E. 95TH ST. |
| Manufacturer City | REDMOND WA 98052 |
| Manufacturer Country | US |
| Manufacturer Postal | 98052 |
| Manufacturer Phone | 4252422154 |
| 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 | IMMUNOADSORPTION COLUMN |
| Product Code | LQQ |
| Date Received | 2006-09-29 |
| Model Number | NA |
| Catalog Number | 9798701 |
| Lot Number | RGN001D |
| ID Number | NA |
| Device Expiration Date | 2007-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 14 MO |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 754894 |
| Manufacturer | FRESENIUS HEMOCARE |
| Manufacturer Address | * REDMOND WA * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2006-09-29 |