MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-11 for MEDIUM, CONTRAST, RADIOLOGIC manufactured by Unk.
[124885263]
I woke up with vertigo although i did not know that at the time. Called 911 and was taken to local hospital where they said they wanted to give me a ct brain scan. I told them i had previously had graves' disease and believed a previous ct scan with contrast several years before had been the cause. The doctor said he had never heard of that and i should get the scan which i did with the iodine contrast. I also had blood taken which were all normal. I was discharged with diagnosis of vertigo and told the scan was clear. I continued to have vertigo episodes and further hospital and doctor visits. After about six weeks a blood test showed my thyroid numbers were all indicating hyperthyroidism and i am now taking medication to return my thyroid to normal. I believe more notice should be taken of this possibility with ct scans.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5080533 |
| MDR Report Key | 7960647 |
| Date Received | 2018-10-11 |
| Date of Report | 2018-10-09 |
| Date of Event | 2018-05-28 |
| Date Added to Maude | 2018-10-12 |
| 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 |
| 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 | MEDIUM, CONTRAST, RADIOLOGIC |
| Generic Name | MEDIUM, CONTRAST, RADIOLOGIC |
| Product Code | KTA |
| Date Received | 2018-10-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2018-10-11 |