MAUDE Adverse Event Report: MYDENT INTERNATIONAL DEFEND; NEEDLE

Model Number DN-3000

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problems Needle Stick/Puncture (2462); Foreign Body In Patient (2687)

Event Date 10/27/2016

Event Type  malfunction  

Event Description

Received notice from a dentist that after injecting the patient, the needle broke in patients mouth.The patient was then sent to a oral surgeon to have it removed.

• Brand Name: DEFEND
• Type of Device: NEEDLE
• Manufacturer (Section D): MYDENT INTERNATIONAL; 80 suffolk court; hauppauge NY 11788
• MDR Report Key: 6109609
• MDR Text Key: 60687557
• Report Number: 2435126-2016-12345
• 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: Manufacturer
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 11/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/11/2017
• Device Model Number: DN-3000
• Device Catalogue Number: DN-3000
• Device Lot Number: 8H120412
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1