MAUDE Adverse Event Report: NEO DENTAL INTERNATIONAL INC. VITAPEX

Device Problem Overfill (2404)

Patient Problems Pain (1994); Burning Sensation (2146); Tingling (2171); Discomfort (2330); Numbness (2415)

Event Date 11/22/2013

Event Type  Injury  

Event Description

Vitapex overfill causing painful dysesthesia and paresthesia.Root canal of tooth number 29.(b)(4).Burning pain has diminished but numbness persists.

• Brand Name: VITAPEX
• Type of Device: VITAPEX
• Manufacturer (Section D): NEO DENTAL INTERNATIONAL INC.
• MDR Report Key: 3727734
• MDR Text Key: 4323773
• Report Number: MW5035459
• Device Sequence Number: 1
• Product Code: KIF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/31/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 66 YR