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 Number: MW1026231
• MDR Report Key: 417566
• Date Received: 2002-09-09
• Date of Report: 2002-09-09
• Date of Event: 2002-09-06
• Date Added to Maude: 2002-09-23
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: PATIENT FAMILY MEMBER OR FRIEND
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: IVORY
• Generic Name: DENTAL CLASP
• Product Code: EMG
• Date Received: 2002-09-09
• Model Number: W2CE
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 406598
• Manufacturer: IVORY
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2002-09-09