inforMED
OtherDYH

PREMIER

Received May 14, 2010 · Event occurred Apr 21, 2010

Report 2511556-2010-00003 · MDR key 1691563

Device

Generic name

Retraction Paste

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.