THERMASEAL PLUS TSLPLUS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-12-03 for THERMASEAL PLUS TSLPLUS manufactured by Dentsply Tulsa Dental Specialties.

Event Text Entries

[5140892] In this event a dentist reported that he had a patient who developed a cyst 3+ years after using thermaseal plus. The patient was referred to an endodontist for treatment.
Patient Sequence No: 1, Text Type: D, B5


[12697891] Because this event necessitated medical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, this event meets the criteria for reportability per 21 cfr part 803. Because the device was used 3+ years ago, it is not available for return, nor is the lot number available for retained-product testing and/or dhr review.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number8010638-2014-00011
MDR Report Key4336197
Report Source05
Date Received2014-12-03
Date of Report2014-11-05
Date Mfgr Received2014-11-05
Date Added to Maude2014-12-18
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationDENTIST
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactHELEN LEWIS
Manufacturer Street221 W. PHILADELPHIA ST., STE. 60 SUSQUEHANNA COMMERCE CENTER W.
Manufacturer CityYORK PA 17401
Manufacturer CountryUS
Manufacturer Postal17401
Manufacturer Phone7178457511
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTHERMASEAL PLUS
Generic NameRESIN, ROOT CANAL FILLING
Product CodeKIF
Date Received2014-12-03
Catalog NumberTSLPLUS
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDENTSPLY TULSA DENTAL SPECIALTIES
Manufacturer AddressJOHNSON CITY TN US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2014-12-03

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