MAUDE Adverse Event Report: CMP INDUSTRIES LLC DENTUREID; RFID CHIP FOR DENTAL APPLIANCE

Model Number D1EN

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

On january 23, 2019 i received an email from customer service forwarding an inquiry from the website.The email was from (b)(6) of (b)(6) dental arts ((b)(6)) requesting that he send back 7 microchips for reimbursement.He stated that a patient had a reaction to the radio frequency or something in the dentureid and had to go to the er.I contacted (b)(6) dental arts and spoke to (b)(6).(b)(6) told me that the dentureid was removed from the patient appliance and was not available for return since the lab disposed of dentureid.The appliance was then returned to the patient for usage.I requested information on what was used to fabricate the appliance and the material used to embed the dentureid on february 1, 5, 8, 18, 19 and 28, 2019.I did not get a definitive answer at this time.I requested patient information and what materials were used to fabricate the dental appliance that were also used with the dentureid microchip.At this time, (b)(6) has not returned my request for information.Received production account on 4/4/19.

Event Description

Dental lab reported that a patient had a reaction to dentureid and had to go the er.

• Brand Name: DENTUREID
• Type of Device: RFID CHIP FOR DENTAL APPLIANCE
• Manufacturer (Section D): CMP INDUSTRIES LLC; 413 north pearl street; albany NY 12207 1311
• Manufacturer Contact: john nicpon ; 413 north pearl street; albany, NY 12207-1311 ; 5184343147
• MDR Report Key: 8492299
• MDR Text Key: 141233375
• Report Number: 1315551-2019-00001
• Device Sequence Number: 1
• Product Code: PYQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170423
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/01/2019

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: No Information
• Device Model Number: D1EN
• Device Catalogue Number: D1EN
• Device Lot Number: 5104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2019
• Initial Date FDA Received: 04/08/2019
• Date Device Manufactured: 06/25/2018
• 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
• Treatment: UNKNOWN DENTURE BASE MATERIAL.
• Patient Outcome(s): Hospitalization