ORTHO SOLO 740-0269

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2004-08-24 for ORTHO SOLO 740-0269 manufactured by Ormco Corporation.

MAUDE Entry Details

Report Number2016150-2004-00003
MDR Report Key886874
Report Source07
Date Received2004-08-24
Date of Report2004-07-20
Date of Event2004-01-01
Date Mfgr Received2004-07-20
Date Added to Maude2007-07-31
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 Street1717 WEST COLLINS AVENUE
Manufacturer CityORANGE CA 92867
Manufacturer CountryUS
Manufacturer Postal92867
Manufacturer Phone7145167425
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 NameORTHO SOLO
Generic NameSEALER AND BOND ENHANCER
Product CodeEBC
Date Received2004-08-24
Model NumberNA
Catalog Number740-0269
Lot NumberUNK
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key864469
ManufacturerORMCO CORPORATION
Manufacturer Address1332 SOUTH LONE HILL AVENUE GLENDORA CA 91740 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2004-08-24

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