inforMED
InjuryEBC

ULTRADENT ULTRASEAL

Received Aug 2, 2011 · Event occurred Jun 9, 2000

Report MW5021619 · MDR key 2195361

Device

Generic name

Dental Sealant

Product problems

  • Device Operates Differently Than Expected

Patient

7 YR

  • Tissue Damage

Narrative

Description of Event or Problem

I PURCHASED DENTAL SEALANTS FOR BOTH MY CHILDREN WITH THE EXPECTATION THAT THEY WOULD PREVENT DECAY. FOR MY CHILDREN, THE OPPOSITE RESULT OCCURRED. RECENT X-RAYS REVEALED MULTIPLE CAVITIES UNDER THREE OF MY DAUGHTER'S SEALANTS, AND SINGULAR CAVITIES UNDER FOUR OF MY SONS. MY DAUGHTER IS (B)(6) AND MY SON IS (B)(6). NEITHER HAVE CAVITIES ELSEWHERE. MY CHILDREN HAVE RECEIVED CONSISTENT DENTAL CARE. MY DAUGHTER'S SEALANTS WERE APPLIED IN 2000 AND 2004. FREQUENCY: 8. DATES OF USE: (B)(6) 2000 - (B)(6) 2006.