ALIKE 4OZ LIQUID
Received Jun 1, 2017 · Event occurred Mar 7, 2017
Report 1410097-2017-00001 · MDR key 6605730
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Hypersensitivity/Allergic reaction
- Burning Sensation
- Hypersensitivity/Allergic reaction
- Burning Sensation
Narrative
Additional Manufacturer Narrative
SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. UNABLE TO REACH PATIENT OR DENTIST.
Description of Event or Problem
GC AMERICA INC. (GCA) RECEIVED A LETTER FROM A PATIENT ON 17 MAR 2017. THE PATIENT HAD RECEIVED DENTAL WORK IN A UNIVERSITY SETTING BY A DENTAL PROVIDER ON 07 MAR 2017. THE PATIENT'S MOUTH BEGAN TO BURN. THE DENTAL PROVIDER HAD USED THE FOLLOWING CHEMICALS: VISCOSTAT, HENRY SCHEIN TEMPORARY CEMENT REMOVER, VPS TRAY ADHESIVE, AND ALIKE LIQUID MONOMER. THE DENTAL PROVIDER PUT VASELINE ON THE PATIENT'S BURNED LIPS AND GAVE THE PATIENT VASELINE TO CONTINUE PUTTING ON THEIR MOUTH. ON (B)(6) 2017, THE PATIENT HAD AN APPOINTMENT WITH THEIR PERSONAL DOCTOR TO EXAMINE THE BURNS AND TO CHECK THEIR HIGH BLOOD PRESSURE. THE PERSONAL DOCTOR PRESCRIBED CEPHALEXIN TO PREVENT AN INFECTION FROM THE BURNS AND SILVER SULFADIAZINE TO AVOID OR TREAT SKIN INFECTIONS FROM THE BURNS. NO ADDITIONAL INFORMATION WAS OBTAINED.