IVORY W2CE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-09-09 for IVORY W2CE * manufactured by Ivory.

Event Text Entries

[268313] In dental office, dentist applied clasp which broke in half. Piece lodged in throat, face turned purple for a few seconds. X-ray showed portion of clasps in stomach and pt "passed" the next day. Pending follow-up x-ray pt has the broken off portion of clasp.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1026231
MDR Report Key417566
Date Received2002-09-09
Date of Report2002-09-09
Date of Event2002-09-06
Date Added to Maude2002-09-23
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT FAMILY MEMBER OR FRIEND
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameIVORY
Generic NameDENTAL CLASP
Product CodeEMG
Date Received2002-09-09
Model NumberW2CE
Catalog Number*
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device Availability*
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key406598
ManufacturerIVORY
Manufacturer Address* * *


Patients

Patient NumberTreatmentOutcomeDate
10 2002-09-09

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