3M¿ SMARTCLIP¿ SL3 SELF-LIGATING BRACKETS

Additional Manufacturer Narrative

A SAMPLE WAS NOT RETURNED FOR ANALYSIS. A LOT NUMBER WAS PROVIDED. THE COMPLAINT HISTORY WAS REVIEWED AND THERE ARE NO ADVERSE TRENDS. THE INSTRUCTIONS FOR USE (IFU) CONTAINS STATEMENTS THAT ACRYLATE MONOMERS ARE KNOWN TO PRODUCE ALLERGIC SKIN REACTIONS IN CERTAIN SENSITIVE INDIVIDUALS AND MAY CAUSE EYE AND SKIN IRRITATION, AND ALSO FOR NICKEL AND/OR CHROMIUM, WHERE A SMALL PERCENTAGE OF THE POPULATION IS KNOWN TO BE ALLERGIC TO NICKEL AND/OR CHROMIUM. SOLVENTUM WILL CONTINUE TO MONITOR.

Description of Event or Problem

A SEVERE ALLERGIC REACTION WAS ALLEGED WHERE A PATIENT EXPERIENCED SWOLLEN LIPS AND BREATHING ISSUES. MEDICAL TREATMENT WITH CORTICOSTEROIDS WERE GIVEN. THE PATIENT HAS A KNOWN ALLERGY AGAINST SILICONE THAT WAS NOT KNOWN BY THE ORTHODONTIST PRIOR TO ORTHODONTIC TREATMENT. THE SYMPTOMS RESOLVED.