ULTRADENT ULTRASEAL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-08-02 for ULTRADENT ULTRASEAL manufactured by Ultradent Products, Inc..

Event Text Entries

[1994212] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5021618
MDR Report Key2195358
Date Received2011-08-02
Date of Report2011-08-02
Date of Event2004-01-01
Date Added to Maude2011-08-15
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT FAMILY MEMBER OR FRIEND
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameULTRADENT ULTRASEAL
Generic NameDENTAL SEALANTS
Product CodeEBC
Date Received2011-08-02
Returned To Mfg2011-08-03
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Sequence No1
Device Event Key0
ManufacturerULTRADENT PRODUCTS, INC.
Manufacturer Address505 W. 10200 S. SOUTH JORDAN UT 84095 US 84095


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2011-08-02

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