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 06 report with the FDA on 2011-05-02 for MIRROR - DBL SIDED, SZ 5 67723 manufactured by Integra, York - Imiltex.

Event Text Entries

[2149408] On (b)(6) 2011 dentist reports by phone that only one of the two mirrors that they returned had the reflective glass fall apart when the dental hygienist was cleaning the pt's teeth. He says that there was potential for harm because the pt could have swallowed it. There was no pt harm.
Patient Sequence No: 1, Text Type: D, B5


[9121194] To date the device involved in the reported incident has not been received for eval. An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2523190-2011-00025
MDR Report Key2097084
Report Source06
Date Received2011-05-02
Date of Report2011-05-02
Date Mfgr Received2011-04-21
Date Added to Maude2011-09-23
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 ContactSANDRA LEE
Manufacturer Street311 ENTERPRISE DR
Manufacturer CityPLAINSBORO NJ 08536
Manufacturer CountryUS
Manufacturer Postal08536
Manufacturer Phone6099366828
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 Received2011-05-02
Catalog Number67723
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerINTEGRA, YORK - IMILTEX
Manufacturer AddressYORK PA 17402 US 17402


Patients

Patient NumberTreatmentOutcomeDate
10 2011-05-02

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