ORTHOGAP

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-02-28 for ORTHOGAP manufactured by Orthogap, Inc..

Event Text Entries

[14790] No msds report available. Is not using fd & c approved pigments.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1005277
MDR Report Key20033
Date Received1995-02-28
Date Added to Maude1995-03-01
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameORTHOGAP
Generic NameORTHODONTIC MARKER
Product CodeEMP
Date Received1995-02-28
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key19927
ManufacturerORTHOGAP, INC.
Manufacturer AddressTAMPA FL 336133913 US


Patients

Patient NumberTreatmentOutcomeDate
10 1995-02-28

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