MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-08-10 for PROSORBA COLUMN 9798701 manufactured by Fresenius Hemocare.
[435474]
Patient developed lower leg pain and "vein distension" on right leg after 2 treatments. Diagnosed with superficial venous thrombosis. Patient was anticogulated and discharged. Patient was being treated for an off-label condition mgus associated neuropathy.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 3032792-2005-00016 |
MDR Report Key | 625813 |
Report Source | 05 |
Date Received | 2005-08-10 |
Date of Event | 2005-07-14 |
Date Mfgr Received | 2005-07-14 |
Device Manufacturer Date | 2005-01-01 |
Date Added to Maude | 2005-08-15 |
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 | 0 |
Manufacturer Contact | JOE WINSLOW |
Manufacturer Street | 14715 NE 95TH ST, STE 100 |
Manufacturer City | REDMOND WA 98052 |
Manufacturer Country | US |
Manufacturer Postal | 98052 |
Manufacturer Phone | 4252422000 |
Manufacturer G1 | FRESENIUS HEMOCARE |
Manufacturer Street | 14715 NE 95TH ST, STE 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 | IMMUNOADSORPTION COLUMN |
Product Code | LQQ |
Date Received | 2005-08-10 |
Model Number | 9798701 |
Catalog Number | 9798701 |
Lot Number | RAN002C |
ID Number | * |
Device Expiration Date | 2006-07-01 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | N |
Implant Flag | N |
Date Removed | A |
Device Sequence No | 1 |
Device Event Key | 615441 |
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. Hospitalization | 2005-08-10 |