MIRROR - DBL SIDED, SZ 5 67723

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-11-21 for MIRROR - DBL SIDED, SZ 5 67723 manufactured by Integra York, Pa Inc..

Event Text Entries

[17102382] The dental assistant reported the adhesive "gave way" and caused the mirrors to come apart and fall into the pt's mouth. There was no injury.
Patient Sequence No: 1, Text Type: D, B5


[17405571] The device involved in the reported incident was discarded by the user facility and is not available for eval. An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2523190-2011-00082
MDR Report Key2394580
Report Source05,06
Date Received2011-11-21
Date of Report2011-11-21
Date Mfgr Received2011-11-07
Date Added to Maude2012-07-18
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationDENTAL HYGIENIST
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactCAREN FERNANDEZ
Manufacturer Street315 ENTERPRISE DR
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 5
Generic NameM52 - HYGIENE / PERIODONTAL
Product CodeEAX
Date Received2011-11-21
Catalog Number67723
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
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 2011-11-21

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