MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-12 for MRI IMAGING manufactured by Unk.
[77633927]
I was given a mri with a gadolinium contrast iv to image my lower extremities in a test for kidney issues. The test instantly caused nausea, hives, and an histamine like reaction throughout my body. After the test and still continuing a year later, i have been suffering deep bone pain, lesions on my skin, and joint pain.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5070398 |
| MDR Report Key | 6639633 |
| Date Received | 2017-06-12 |
| Date of Report | 2017-06-12 |
| Date of Event | 2016-06-20 |
| Date Added to Maude | 2017-06-14 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MRI IMAGING |
| Generic Name | SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING |
| Product Code | LNH |
| Date Received | 2017-06-12 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Brand Name | GADOLINIUM CONTRAST |
| Generic Name | MEDIUM, CONTRAST, RADIOLOGIC |
| Product Code | KTA |
| Date Received | 2017-06-12 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-06-12 |