FDA Adverse Event
Injury
Summary report: N
DENTAL CAP SCAN
MDR report key: 3905583
·
Received June 30, 2014
Report
- Report Number
- MW5036896
- Event Type
- Injury
- Date Received
- June 30, 2014
- Date of Event
- May 23, 2014
- Report Date
- June 30, 2014
- Manufacturer
- UNK
- Product Code
- NOF
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- AZ, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
THE REPORTER HAD SEVERAL PROBLEMS AT VARIOUS STAGES OVER THE NEXT 3 WEEKS. SHE HAD A DAY OF TINGLING IN THE MOUTH AND THROAT THAT LASTED FOR SEVERAL DAYS, PAIN AND TINGLING AT THE BASE OF HER TEETH THAT WAS SIGNIFICANT BUT DID NOT LAST A LONG. ALSO HAD SWOLLEN SALIVA GLANDS. THE DAY FOLLOWING THE SCAN HER NOSE WAS RUNNING LIKE A FAUCET. ALSO HAD DIFFICULTY SWALLOWING ESPECIALLY CAPSULES AND TABLETS, SHORTNESS OF BREATH AND HER THROAT FELT SWOLLEN. THIS LASTED FOR ABOUT 3 WEEKS. ALSO HAD A PROBLEM WITH MUSCULAR CONTROL; DIFFICULTY WALKING AND LIFTING OBJECTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 380044 | DENTAL CAP SCAN | DENTAL SCAN | NOF | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR |