EXPLORER DE #5 * 100-8008

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-12-22 for EXPLORER DE #5 * 100-8008 manufactured by Shanghai Dental Instrument Factory.

Event Text Entries

[376052] The tip of an explorer broke off during a routine dental exam and was swallowed by the pt who was then able to regurgitate the tip. Pt is well.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2411236-2004-13070
• MDR Report Key: 561237
• Date Received: 2004-12-22
• Date of Report: 2004-12-22
• Date of Event: 2004-12-10
• Date Facility Aware: 2004-12-13
• Report Date: 2004-12-22
• Date Reported to FDA: 2004-12-22
• Date Added to Maude: 2004-12-27
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• 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
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Manufacturer Phone: **
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: EXPLORER DE #5
• Generic Name: DENTAL INSTRUMENT
• Product Code: EKB
• Date Received: 2004-12-22
• Returned To Mfg: 2004-12-22
• Model Number: *
• Catalog Number: 100-8008
• Lot Number: 0603
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Eval'ed by Mfgr: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 550941
• Manufacturer: SHANGHAI DENTAL INSTRUMENT FACTORY
• Manufacturer Address: 820 LINGSHI RD SHANGHAI CH
• Baseline Brand Name: EXPLORER DE #5
• Baseline Generic Name: DENTAL INSTRUMENT
• Baseline Model No: *
• Baseline Catalog No: 100-8008
• Baseline ID: *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2004-12-22