SYSTEM B HEAT SOURCE 952-0001

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 2013-07-12 for SYSTEM B HEAT SOURCE 952-0001 manufactured by Sybronendo.

Event Text Entries

[11074058] A visual and physical evaluation of the returned device revealed that a spring was bent on the device, causing constant heating.
Patient Sequence No: 1, Text Type: N, H10


[20354398] A doctor alleged that the system b heat source device continued to heat after being unplugged and the doctor had burned the index finger on his left hand while attempting to remove the tip.
Patient Sequence No: 1, Text Type: D, B5


[20556411] The doctor confirmed that no medical attention or prescription medication was required. The doctor iced his hand for a brief period and the burn healed on its own after a few days. A device evaluation is anticipated, but has not yet begun.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2016150-2013-00071
MDR Report Key3222655
Report Source05
Date Received2013-07-12
Date of Report2013-06-13
Date Mfgr Received2013-06-13
Date Added to Maude2013-10-03
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactMRS. KERRI CASINO
Manufacturer Street1717 W. COLLINS AVE
Manufacturer CityORANGE CA 29867
Manufacturer CountryUS
Manufacturer Postal29867
Manufacturer Phone7145167634
Manufacturer G1SYBRONENDO
Manufacturer Street1332 SOUTH LONE HILL AVENUE
Manufacturer CityGLENDORA CA 91740
Manufacturer CountryUS
Manufacturer Postal Code91740
Single Use0
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSYSTEM B HEAT SOURCE
Generic NamePULP TESTER
Product CodeEAT
Date Received2013-07-12
Catalog Number952-0001
Lot Number15-1908
OperatorOTHER
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSYBRONENDO
Manufacturer Address1332 SOUTH LONE HILL AVENUE GLENDORA CA 91740 US 91740


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2013-07-12

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