SYBRONENDO 952-0004

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-06-22 for SYBRONENDO 952-0004 manufactured by Sybronendo.

Event Text Entries

[112040678] No patient information was provided in regards to weight, ethnicity, and race. Date of event was not provided. No information was provided in regards to the serial number, therefore device manufacturing date could not be determined. This will be twenty (20) of twenty-four (24) medical device reports that will be submitted. 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


[112040679] An alleged complaint was reported that multiple patients suffered a tougher post-operative recovery. They felt a very high sensitivity due to higher heat.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2016150-2018-00041
MDR Report Key7629849
Report SourceDISTRIBUTOR
Date Received2018-06-22
Date of Report2018-06-21
Date Mfgr Received2018-06-21
Date Added to Maude2018-06-22
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 Received2018-06-22
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 2018-06-22

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