MAUDE Adverse Event Report: HENRY SCHEIN, INC. UNKNOWN; INSTRUMENTS, DENTAL HAND

Model Number EC3 / SG13/14 / 13/14 101-60540716-N

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Date 09/29/2017

Event Type  malfunction  

Event Description

A metal piece from a root tip pick broke off inside of the patient's mouth during a dental procedure.

• Brand Name: UNKNOWN
• Type of Device: INSTRUMENTS, DENTAL HAND
• Manufacturer (Section D): HENRY SCHEIN, INC.; 85 maple st; stoneham MA 02180
• MDR Report Key: 6954286
• MDR Text Key: 89499271
• Report Number: 6954286
• Device Sequence Number: 1
• Product Code: DZN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: EC3 / SG13/14 / 13/14 101-60540716-N
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/06/2017
• Event Location: Hospital
• Date Report to Manufacturer: 10/06/2017
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES; NOT AT THAT TIME