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 2016-10-19 for 3M TRUE DEFINITION SCANNER 78007 manufactured by 3m Espe Dental Products.
[57922994]
An in office electrical evaluation was conducted and found that the outlet in the dental office was non-conforming, as it was not appropriately grounded for the connection to the 3m true definition scanner. Appropriate electrical safety measures (isolation transformer) are provided with the true definition scanner system. The 3m true definition scanner instructions for use does contain the warning, 'to reduce the risks associated with hazardous voltage and fire - use only a properly grounded power outlet; do not use extension cords or multiple portable power socket outlets.
Patient Sequence No: 1, Text Type: N, H10
[57922995]
On (b)(6) 2016, it was reported that a female patient in (b)(6) experienced an electrical impulse during use of the 3m true definition scanner.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005174370-2016-00113 |
| MDR Report Key | 6042702 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-10-19 |
| Date of Report | 2016-09-22 |
| Date of Event | 2016-09-20 |
| Date Mfgr Received | 2015-09-22 |
| Date Added to Maude | 2016-10-19 |
| 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 | DENTIST |
| 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 | 2016-10-19 |
| Catalog Number | 78007 |
| Operator | DENTIST |
| 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 | 2016-10-19 |