DAMON UTILITY OPENING/CLOSING PLIER 866-4006

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-04-27 for DAMON UTILITY OPENING/CLOSING PLIER 866-4006 manufactured by Ormco Corp..

Event Text Entries

[16480045] In april 2006 a doctor informed ormco corporation that he had a damon utilit opening/closing plier with a broken tip insert, braze failure.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2016150-2006-00032
MDR Report Key705765
Report Source05
Date Received2006-04-27
Date of Report2006-04-03
Date of Event2006-04-01
Date Mfgr Received2006-04-03
Device Manufacturer Date2004-11-01
Date Added to Maude2006-05-02
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 FDA3
Event Location0
Manufacturer ContactWENDY URTEL
Manufacturer Street100 BAYVIEW CIRCLE SUITE 6000
Manufacturer CityNEWPORT BEACH CA 92660
Manufacturer CountryUS
Manufacturer Postal92660
Manufacturer Phone9492558767
Manufacturer G1ORMCO CORPORATION
Manufacturer Street1332 SOUTH LONE HILL AVENUE
Manufacturer CityGLENDORA CA 91740
Manufacturer CountryUS
Manufacturer Postal Code91740
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDAMON UTILITY OPENING/CLOSING PLIER
Generic NamePLIER, ORTHODONTIC
Product CodeJEX
Date Received2006-04-27
Returned To Mfg2006-04-03
Model NumberNA
Catalog Number866-4006
Lot Number04L38L
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrN
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key694832
ManufacturerORMCO CORP.
Manufacturer Address1332 SOUTH LONE HILL AVE. GLENDORA CA 91740 US
Baseline Brand NameDAMON UTILITY OPENING/CLOSING PLIER
Baseline Generic NameORTHODONTIC PLIER
Baseline Model NoNA
Baseline Catalog No866-4006
Baseline IDNA
Baseline Device FamilyPLIER, ORTHODONTIC
Baseline Shelf Life [Months]NA
Baseline PMA FlagN
Baseline 510K PMNN
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptY


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2006-04-27

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