SYBRONENDO 952-0004

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 2018-03-28 for SYBRONENDO 952-0004 manufactured by Sybronendo.

Event Text Entries

[103933546] No patient information was provided in regards to age, sex, weight, ethnicity, and race. Date of event is approximated based on the information provided. No information was provided in regards to the serial number, therefore device manufacturing date could not be determined. No injuries or medical intervention was reported. The product has been identified as an affected product in an ongoing class ii recall; therefore no further evaluation is necessary.
Patient Sequence No: 1, Text Type: N, H10


[103933547] Over the past six months, the doctor recalled approximately 2-3 instances of patients indicating that they felt heat during endodontic procedures. It was reported that there were no patient injuries or medical intervention.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2016150-2018-00012
MDR Report Key7379272
Report SourceHEALTH PROFESSIONAL
Date Received2018-03-28
Date of Report2018-03-27
Date of Event2017-10-01
Date Mfgr Received2018-03-27
Date Added to Maude2018-03-28
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
Remedial ActionRC
Previous Use Code3
Removal Correction NumberZ-0413-2018
Event Type3
Type of Report3

Device Details

Brand NameSYBRONENDO
Generic NameFINE BUCHANAN PLUGGER
Product CodeEKR
Date Received2018-03-28
Catalog Number952-0004
OperatorDENTIST
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
10 2018-03-28

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