MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-04 for CONTRAST DYE manufactured by .
[41416822]
Had myelogram, radiology. Dye injected in spinal area to see damages to vertebrae area. Fractures to upper vertebrae and lower vertebrae detected. Have to take keppra and pain meds for one more fracture. Injured on the job; (b)(6) in 1993. Lower back injured 3, 45 disc. Refused back surgery, fear from not being able to walk. Injured as a customer at the store. Fractured vertebrae in upper back, 9, 10, 11-12. After x-ray and contrast dye, started having seizures, both lower hips and leg injuries. Now having seizures, fracturing collar bone, clavicle right side, right hand, left shoulder, neck and head injury. Tried to avoid surgery. Now needing to have surgery, myelogram and contrast dye. (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5061281 |
| MDR Report Key | 5529215 |
| Date Received | 2016-03-04 |
| Date of Report | 2016-03-02 |
| Date of Event | 2008-01-02 |
| Date Added to Maude | 2016-03-28 |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CONTRAST DYE |
| Generic Name | CONTRAST DYE |
| Product Code | KTA |
| Date Received | 2016-03-04 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Deathisabilit | 2016-03-04 |