OtherDYH
PREMIER
Received May 14, 2010 · Event occurred Apr 21, 2010
Report 2511556-2010-00003 · MDR key 1691563
Device
Generic name
Retraction Paste
Manufacturer
Premier Dental Products Co.Catalog number
9007091
Lot number
5813
Product problems
- Patient-Device Incompatibility
Patient
Not reported
- Hypersensitivity/Allergic reaction
- Pain
- Swelling
Narrative
Description of Event or Problem
DENTIST WAS WORKING ON TOOTH #31 AND NUMBED THE PATIENT WITH POLOCAINE BEFORE BEGINNING THE PROCEDURE. THE PATIENT'S FACE INSTANTLY SWELLED AFTER ADMINISTERING THE TRAXODENT RETRACTION MATERIAL. PATIENT HAD AN ALLERGIC REACTION AND WAS SENT TO THE EMERGENCY ROOM WHERE SHE WAS GIVEN BENADRYL IV. ON (B)(6) 2010, THE OFFICE REPORTED THE PATIENT WAS STILL SORE AND SWOLLEN BUT DOING MUCH BETTER THAN THE DAY BEFORE. THE OFFICE HAS USED TRAXODENT ON OTHER PATIENTS WITHOUT ANY PROBLEMS.