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