VANISH 5% SODIUM FLORIDE WHITE VARNISH

Description of Event or Problem

A MALE PATIENT HAD VANISH APPLIED IN 2007. SYMPTOMS ARE REPORTED TO HAVE STARTED ABOUT ONE HOUR AFTER PRODUCT PLACEMENT AND INCLUDED SWELLING OF LIPS. THE PATIENT'S MOTHER CONTACTED THE TREATING DENTIST THE FOLLOWING DAY AND REPORTED THAT THE SWELLING WAS WORSE THAN IT WAS ON THE PRIOR DAY AND THAT IT WAS SPREADING TO INVOLVE THE FACE, APPROACHING THE EYES. MEDICAL ATTENTION WAS SOUGHT AND AT THE SAME POINT, THE PATIENT WAS HOSPITALIZED FOR TREATMENT. INFORMATION PROVIDED TO 3M ESPE OMNI, INDICATES THAT TREATMENT CONSISTED OF PREDNISONE FOR WHAT IS DESCRIBED AS A WHOLE BODY RASH. IT IS NOT KNOWN BY 3M ESPE OMNI WHEN THE RASH DEVELOPED.

Additional Manufacturer Narrative

THE ORIGINAL REPORT CAME TO 3M ESPE OMNI IN 2007 FROM THE TREATING DENTIST. A SECOND CALL CAME INTO THE 3M ON TWO DAYS LATER, FROM THE PHYSICIAN PROVIDING THE HOSPITAL-BASED CARE. FROM THE INITIAL INFORMATION PROVIDED, IT WAS NOT READILY APPARENT THAT THESE TWO CALLS WERE RELATED. H6: DEVICE NOT RETURNED TO MANUFACTURER; THEREFORE, NO EVALUATION WAS CONDUCTED; NO CONCLUSION COULD BE DRAWN.