MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-09-20 for OMNISCAN 300 manufactured by Ge.
[691079]
Biopsy proven nfd/nfs. Unknown date of biopsy given gadolinium: 2003, 20cc omniscan. The following day, 30cc omniscan developed leg pain and rash in approx three months later, prior to development of end stage renal disease.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5003833 |
| MDR Report Key | 917860 |
| Date Received | 2007-09-20 |
| Date of Report | 2007-09-20 |
| Date of Event | 2003-07-01 |
| Date Added to Maude | 2007-09-28 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OMNISCAN 300 |
| Generic Name | NONE |
| Product Code | KTA |
| Date Received | 2007-09-20 |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 891829 |
| Manufacturer | GE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2007-09-20 |