MAUDE Adverse Event Report:

Device Problems Break (1069); Fracture (1260)

Patient Problems Surgical procedure (2357); Foreign body, removal of (2365)

Event Date 06/25/2014

Event Type  Injury  

Event Description

Transfer to hospital after being seen by a general dentist for teeth extraction.During injection with local anesthesia, the needle from the syringe broke off into patient's right cheek.Unsuccessful attempt to remove by dentist and maxillofacial surgeon.Required hospitalization and general anesthesia to remove foreign body.

• Brand Name: UNK
• Type of Device: UNK
• MDR Report Key: 3947196
• MDR Text Key: 4600549
• Report Number: 3947196
• Device Sequence Number: 1
• Product Code: DZM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/08/2014
• Distributor Facility Aware Date: 07/04/2014
• Event Location: Outpatient Treatment Facility
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 33 YR
• Patient Weight: 116