MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2019-04-08 for DENTUREID D1EN manufactured by Cmp Industries Llc.
[141233375]
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.
Patient Sequence No: 1, Text Type: N, H10
[141233376]
Dental lab reported that a patient had a reaction to dentureid and had to go the er.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1315551-2019-00001 |
| MDR Report Key | 8492299 |
| Report Source | OTHER |
| Date Received | 2019-04-08 |
| Date of Report | 2019-03-01 |
| Date Mfgr Received | 2019-01-23 |
| Device Manufacturer Date | 2018-06-25 |
| Date Added to Maude | 2019-04-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR JOHN NICPON |
| Manufacturer Street | 413 NORTH PEARL STREET |
| Manufacturer City | ALBANY NY 122071311 |
| Manufacturer Country | US |
| Manufacturer Postal | 122071311 |
| Manufacturer Phone | 5184343147 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DENTUREID |
| Generic Name | RFID CHIP FOR DENTAL APPLIANCE |
| Product Code | PYQ |
| Date Received | 2019-04-08 |
| Model Number | D1EN |
| Catalog Number | D1EN |
| Lot Number | 5104 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CMP INDUSTRIES LLC |
| Manufacturer Address | 413 NORTH PEARL STREET ALBANY NY 122071311 US 122071311 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-04-08 |