UNC CC, SE PROBE, 1-12, RESINEIGHT HDL

Description of Event or Problem

FOLLOWING A DENTAL APPOINTMENT, THE PATIENT DEVELOPED A RASH ON HER FACE AND ARM. SHE LATER CONSULTED HER PHYSICIAN, WHO DETERMINED THAT THE SYMPTOMS WERE LIKELY CAUSED BY AN ALLERGIC REACTION TO COBALT PRESENT IN THE DENTAL INSTRUMENTS USED DURING THE PROCEDURE.

Additional Manufacturer Narrative

INVESTIGATION IS ONGOING. THE DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION. A DEFINITIVE ROOT CAUSE HAS NOT BEEN ESTABLISHED AT THIS TIME. ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION WILL BE CLOSED.