MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-08-04 for CATSCAN manufactured by .
[1359787]
After catscan, patient started experiencing tinnitus which is affected by pressure on jaw. Suspects damage to inner ear by levels of radiation. After having an xray on (b)(6) 2009, patient began having intolerable levels of discomfort due to tinnitus. This has affected quality of life and work abilities. Patient has also experienced fatigue, swelling in throat, and 4 lipomas which he feels may be related to radiation dosage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5016997 |
| MDR Report Key | 1789295 |
| Date Received | 2010-08-04 |
| Date of Report | 2010-08-04 |
| Date of Event | 1994-01-01 |
| Date Added to Maude | 2010-08-11 |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | CATSCAN |
| Product Code | JAK |
| Date Received | 2010-08-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Generic Name | XRAY |
| Product Code | IZO |
| Date Received | 2010-08-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-08-04 |