REALSEAL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-11-01 for REALSEAL manufactured by Sybronendo.

Event Text Entries

[125909586] Specific patient information with regards to age, gender, ethnicity, race and weight was not provided. No lot number was provided therefore manufacture date cannot be determined. The product was not returned and no lot number or part number was provided; therefore, no evaluation can be conducted.
Patient Sequence No: 1, Text Type: N, H10


[125909587] A complainant alleged that when performing a resilon re-treatment the following was noted, breakdown of the resilon material, gooey, soft, and periapical infection. The case was retreated with gentle wave. It was reported that there are no internal fractures and prognosis fair to good.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2016150-2018-00059
MDR Report Key8031283
Report SourceHEALTH PROFESSIONAL
Date Received2018-11-01
Date of Report2018-11-01
Date Mfgr Received2018-11-01
Date Added to Maude2018-11-01
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 FDA3
Event Location3
Manufacturer ContactMR. PAULO CALLE
Manufacturer Street1717 W COLLINS AVENUE
Manufacturer CityORANGE CA 92867
Manufacturer CountryUS
Manufacturer Postal92867
Manufacturer Phone7145167752
Manufacturer G1SYBRONENDO
Manufacturer Street1332 SOUTH LONE HILL AVENUE
Manufacturer CityGLENDORA CA 91740
Manufacturer CountryUS
Manufacturer Postal Code91740
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameREALSEAL
Generic NameRESIN, ROOT CANAL FILLING,
Product CodeKIF
Date Received2018-11-01
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSYBRONENDO
Manufacturer Address1332 SOUTH LONE HILL AVENUE GLENDORA CA 91740 US 91740


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-11-01

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