SOMNODENT FLEX
Received May 12, 2016 · Event occurred Nov 25, 2015
Report 3005598536-2016-00002 · MDR key 5651214
Device
Product problems
- Device Appears to Trigger Rejection
- Device Appears to Trigger Rejection
Patient
Not reported
- Hypersensitivity/Allergic reaction
- Anxiety
- Discomfort
- Hypersensitivity/Allergic reaction
- Anxiety
- Discomfort
Narrative
Additional Manufacturer Narrative
ALTHOUGH BIOCOMPATIBILITY TESTING WAS TESTED TO THE STANDARD, SOME PATIENTS MAY EXPERIENCE HYPERSENSITIVITY AND/OR AN ALLERGIC REACTION DUE TO BIOLOGICAL VARIATIONS IN THEIR IMMUNE SYSTEM. THE COMPLAINT TREND IS CLOSELY TRACKED AND TRENDED AS THE FREQUENCY IS LOW.
Description of Event or Problem
A FEMALE, ADULT PATIENT APPEARED TO BE HAVING AN ALLERGIC REACTION TO THE DEVICE. SOMNOMED BECAME AWARE ON 4/28/16 THAT A PATIENT GOING TO THE ER/URGENT CARE FACILITY FOR OBSERVATION/TREATMENT SHOULD HAVE BEEN CONSERVATIVELY REPORTED. THE PATIENT WAS ADMINISTERED MEDICAL INTERVENTION THAT CONSISTED OF BENADRYL AND SOMETHING TO MAKE THE PATIENT RELAX. THE PATIENT WAS AT THE CARE FACILITY FOR A TOTAL OF 1 HOURS. THIS WAS INITIALLY CONSIDERED TO BE A MINOR INJURY BY SOMNOMED, AS THE PATIENT DID NOT SUFFER FROM ANAPHYLAXIS AND WAS NOT ADMINISTERED AN EPIPEN. THE PATIENT WAS ALSO REPORTED TO BE IN FINE CONDITION FROM THE TREATING DENTIST.