MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2015-11-25 for 3M TRUE DEFINITION SCANNER 75030 manufactured by 3m Espe Dental Products.
[32194950]
Appropriate electrical safety measures (isolation transformer) are present in 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
[32194951]
During a scanning procedure using a 3m true definition scanner, a patient experienced a shock and pain inside the mouth. It was confirmed that the power outlet, where the scanner was connected at the time the incident occurred, was not properly grounded. After the scanner was plugged into the power outlet where the ground was proven to be wired and functioning properly, no more shocks occurred. The dentist was advised of the investigation findings and agreed that the incident was caused by the faulty power outlet at the office; an electrician was called and fixed all power outlets in the office.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005174370-2015-00112 |
| MDR Report Key | 5251988 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2015-11-25 |
| Date of Report | 2015-10-29 |
| Date of Event | 2012-03-27 |
| Date Mfgr Received | 2015-10-29 |
| Date Added to Maude | 2015-11-25 |
| 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 | 2015-11-25 |
| Catalog Number | 75030 |
| Lot Number | G1525065 |
| Operator | DENTIST |
| Device Availability | N |
| 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 | 2015-11-25 |