EXA'LENCE REGULAR HEAVY 48 ML
Received Feb 27, 2018 · Event occurred Jan 30, 2018
Report 1410097-2018-00001 · MDR key 7301236
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Patient-Device Incompatibility
- Material Integrity Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Hypersensitivity/Allergic reaction
- Hypersensitivity/Allergic reaction
Narrative
Description of Event or Problem
THE PATIENT DID HAVE A KNOWN ALLERGY TO MINT. THE DENTIST HAD AN IMPRESSION MATERIAL THAT THEY KNEW HAD A MINT IN IT AND COULDN'T USE AND DECIDED TO USE EXA'LENCE INSTEAD. THE DENTIST WAS UNAWARE THAT EXA'LENCE HAD ANY MINT FLAVOR IN IT BECAUSE THEY COULD NOT FIND ANY INFORMATION ON THE BOX. AFTER THE PATIENT LEFT THE OFFICE, SHE CONTACTED THE DENTIST OFFICE VIA EMAIL INFORMED THAT SHE WAS EXPERIENCING RESPIRATORY LIKE SYMPTOMS AND CONTACTED HER PHYSICIAN. THE DENTIST OFIICE STATED THAT THE PATIENT TOOK BENADRYL AND IT ALLEVIATED THE PROBLEM AND SHE IS FINE AT THIS TIME.
Additional Manufacturer Narrative
WE WILL REVIEW INSTRUCTIONS FOR USE OF THE DEVICE TO IMPROVE THE INFORMATION ON POTENTIAL ALLERGENS.
Description of Event or Problem
THE PATIENT DID HAVE A KNOWN ALLERGY TO MINT. THE DENTIST HAD AN IMPRESSION MATERIAL THAT THEY KNEW HAD A MINT IN IT AND COULDN'T USE AND DECIDED TO USE EXA'LENCE INSTEAD. THE DENTIST WAS UNAWARE THAT EXA'LENCE HAD ANY MINT FLAVOR IN IT BECAUSE THEY COULD NOT FIND ANY INFORMATION ON THE BOX. AFTER THE PATIENT LEFT THE OFFICE, SHE CONTACTED THE DENTIST OFFICE VIA EMAIL INFORMED THAT SHE WAS EXPERIENCING RESPIRATORY LIKE SYMPTOMS AND CONTACTED HER PHYSICIAN. THE DENTIST OFIICE STATED THAT THE PATIENT TOOK BENADRYL AND IT ALLEVIATED THE PROBLEM AND SHE IS FINE AT THIS TIME.
Remedial action
- Other