EXPLORER SE #23 * 1003620

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-02-17 for EXPLORER SE #23 * 1003620 manufactured by Shanghai Dental Instrument Factory.

Event Text Entries

[359578] Notification received of an explorer tip breaking off in a pt's mouth. The pt subsequently swallowed the tip. Pt had x-rays taken and to the reporter's knowledge is fine.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2411236-2004-10831
• MDR Report Key: 511767
• Date Received: 2004-02-17
• Date of Report: 2004-02-17
• Date of Event: 2003-12-01
• Date Facility Aware: 2004-02-16
• Report Date: 2004-02-17
• Date Reported to FDA: 2004-02-17
• Date Added to Maude: 2004-02-19
• Event Key: 0
• Report Source Code: Distributor report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: DENTIST
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: EXPLORER SE #23
• Generic Name: DENTAL INSTRUMENT
• Product Code: EKB
• Date Received: 2004-02-17
• Model Number: *
• Catalog Number: 1003620
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 500755
• Manufacturer: SHANGHAI DENTAL INSTRUMENT FACTORY
• Manufacturer Address: 820 LING SHI RD SHANGHAI CH

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2004-02-17