MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2006-02-06 for IMMUNOSORBA COLUMN 9797200 manufactured by Fresenius Hemocare.
[16824524]
A pt with morbus wegener (medical condition) and resulting renal failure received 10 immunosorba (ia) treatments for three months in 2002 with one pair of ia columns. Pt responded well to treatment but developed elevated mercury, 305 ug/l after 9th treatment with symptoms of tremor, weakness, unclear speech, poor memory, dyspnea, dizziness and aggressiveness. The pt was admitted to a "detoxification center. " his hg level at discharge was 20 ug/l. Adverse event occurred outside the united states.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3033270-2006-00003 |
| MDR Report Key | 671424 |
| Report Source | 01,05 |
| Date Received | 2006-02-06 |
| Date of Report | 2006-02-03 |
| Date of Event | 2002-05-07 |
| Report Date | 2006-02-03 |
| Date Mfgr Received | 2003-03-31 |
| Date Added to Maude | 2006-02-07 |
| 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 NE 95TH ST, STE 100 |
| 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 | IMMUNOSORBA COLUMN |
| Generic Name | IMMUNOADSORPTION COLUMN |
| Product Code | LQQ |
| Date Received | 2006-02-06 |
| Model Number | 9797200 |
| Catalog Number | 9797200 |
| Lot Number | C1051-3-4 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNK |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 660746 |
| Manufacturer | FRESENIUS HEMOCARE |
| Manufacturer Address | * REDMOND WA * US |
| Baseline Brand Name | IMMUNOSORBA COLUMN |
| Baseline Generic Name | IMMUNOADSORPTION SYSTEM |
| Baseline Catalog No | 9797200 |
| Baseline Device Family | IMMUNOADSORPTION COLUMN |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 12 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-02-06 |