MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-12-21 for 3M TRUE DEFINITION SCANNER 78052 manufactured by 3m Espe Dental Products.
[63054605]
After the tingling sensation was experienced, the true definition scanner system was unplugged from the electrical outlet and the scan was continued using battery power. No sensation was experienced during the scan using battery power. 3m has requested that the entire true definition scanner unit be returned for testing to ensure the product is operating in specification. 3m is still waiting to receive this unit back. It is anticipated that an electrical site assessment will be conducted at the uk dental office. If any further information becomes available 3m will file a follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[63054606]
On (b)(6) 2016, 3m was notified that a female subject experienced an electrical sensation during a demonstration scanning procedure using the 3m true definition scanner. The subject felt a tingling sensation on lower tooth #2 and #3 and scanning was immediately stopped. No patient injury occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005174370-2016-00154 |
| MDR Report Key | 6196478 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-12-21 |
| Date of Report | 2016-11-23 |
| Date of Event | 2016-11-14 |
| Date Mfgr Received | 2016-11-23 |
| Date Added to Maude | 2016-12-21 |
| 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 | SERVICE PERSONNEL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ANGIE DRAPER |
| Manufacturer Street | 2510 CONWAY AVENUE |
| Manufacturer City | ST. PAUL MN 551441000 |
| Manufacturer Country | US |
| Manufacturer Postal | 551441000 |
| Manufacturer Phone | 6517331179 |
| Manufacturer G1 | 3M ESPE DENTAL PRODUCTS |
| Manufacturer Street | 2510 CONWAY AVENUE |
| Manufacturer City | ST. PAUL MN 551441000 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 551441000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M TRUE DEFINITION SCANNER |
| Generic Name | SYSTEM,OPTICAL IMPRESSION, COMPUTER ASSISTED DESIGN AND MANUFACTURING (CAD/CAM) |
| Product Code | NOF |
| Date Received | 2016-12-21 |
| Catalog Number | 78052 |
| Operator | SERVICE PERSONNEL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M ESPE DENTAL PRODUCTS |
| Manufacturer Address | 2510 CONWAY AVENUE ST. PAUL MN 551441000 US 551441000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-12-21 |