InjuryEBC
ULTRADENT ULTRASEAL
Received Aug 2, 2011 · Event occurred Jan 1, 2004
Report MW5021618 · MDR key 2195358
Device
Generic name
Dental Sealants
Manufacturer
Ultradent Products, Inc.Product problems
- Device Operates Differently Than Expected
Patient
8 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. FREQUENCY: 4. DATES OF USE: (B)(6) 2000 - (B)(6) 2006.