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 2012-06-15 for MIRROR - DBL SIDED, SZ 5 67723 manufactured by Miltex, Inc..

Event Text Entries

[2731009] Mirrors popped out. No pt injury. On (b)(6) 2012 customer reports the pt could have swallowed the mirrors but did not. The customer was unable to single out a particular pt or procedure.
Patient Sequence No: 1, Text Type: D, B5


[9921105] 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 Number2523190-2012-00054
MDR Report Key2623524
Report Source06
Date Received2012-06-15
Date of Report2012-06-15
Date Mfgr Received2012-06-04
Date Added to Maude2012-10-11
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactSANDRA LEE
Manufacturer Street315 ENTERPRISE DR.
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 Received2012-06-15
Catalog Number67723
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMILTEX, INC.
Manufacturer AddressYORK PA 17402 US 17402


Patients

Patient NumberTreatmentOutcomeDate
10 2012-06-15

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