MAXIMA RU1200

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-08 for MAXIMA RU1200 manufactured by Henry Schein.

Event Text Entries

[38108935] Patient was having a composite filing done of tooth #3 when she began to experience a burning sensation inside and outside the mouth while the staff was using the curing light.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5060114
MDR Report Key5431165
Date Received2016-02-08
Date of Report2016-02-08
Date of Event2016-02-02
Date Added to Maude2016-02-11
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameMAXIMA RU1200
Generic NameCURING LIGHT
Product CodeEBZ
Date Received2016-02-08
Model NumberRU1200
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerHENRY SCHEIN
Manufacturer AddressMELVILLE NY US


Patients

Patient NumberTreatmentOutcomeDate
10 2016-02-08

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