MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2006-02-03 for IMMUNOSORBA COLUMN 9797200 manufactured by Fresenius Hemocare.
[19259721]
Pt was myasthenia gravis responded well to 6 months of ia treatment, but then displayed atypical neurologic symptoms of intention tremor. Mercury levels found to be 107 ug/l hg. No information was received regarding medical intervention or the pt outcome in this incident. It is not known whether she was hospitalized. Adverse event occurred outside the united states.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3033270-2006-00002 |
| MDR Report Key | 671307 |
| Report Source | 01,05 |
| Date Received | 2006-02-03 |
| Date of Report | 2006-02-03 |
| Date of Event | 2002-05-06 |
| 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 | 2006-02-03 |
| Model Number | 9797200 |
| Catalog Number | 9797200 |
| Lot Number | UNK |
| 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 | 660627 |
| 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. Other | 2006-02-03 |