MIRROR - DBL SIDED, SZ 4 67722

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,08 report with the FDA on 2012-01-16 for MIRROR - DBL SIDED, SZ 4 67722 manufactured by Integra York, Pa Inc..

Event Text Entries

[16411969] The mirror seemed to come unglued and fell into a patient's mouth. The mirror was retrieved and there was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5


[16569516] To date the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2523190-2012-00010
MDR Report Key2437929
Report Source05,06,08
Date Received2012-01-16
Date of Report2012-01-16
Date Mfgr Received2012-01-13
Date Added to Maude2012-08-06
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 FDA0
Event Location0
Manufacturer ContactCAREN FERNANDEZ
Manufacturer Street315 ENTERPRISE DRIVE
Manufacturer CityPLAINSBORO NJ 08536
Manufacturer CountryUS
Manufacturer Postal08536
Manufacturer Phone6099362341
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMIRROR - DBL SIDED, SZ 4
Generic NameM52 - HYGIENE/PERIODONTAL
Product CodeEAX
Date Received2012-01-16
Catalog Number67722
Lot Number02623
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerINTEGRA YORK, PA INC.
Manufacturer AddressYORK PA 17402 US 17402


Patients

Patient NumberTreatmentOutcomeDate
10 2012-01-16

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