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 2016-07-01 for 3M TRUE DEFINITION SCANNER 75030 manufactured by 3m Espe Dental Products.
[48719203]
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. ' any additional information that becomes available will be submitted as a follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[48719204]
This report details an event in which a patient in france experienced what was reported as an electric tingle on the teeth during use of the 3m true definition scanner in (b)(6) 2015, a female patient reported an electric tingle on the teeth during the passage of the wand. Investigation by the computer manufacturer revealed that the computer was not operating properly; it was returned to the manufacturer for further investigation and 3m was not appraised of the findings.
Patient Sequence No: 1, Text Type: D, B5
[57695108]
A environmental on-site electrical assessment was completed at the dental office by a 3m (b)(4) technician. It was found that the dental office chairs were not ground connected and one of those chairs was also not correctly isolated. 3m instructions for use do contain a warning to "use properly grounded outlets. " in addition, 3m center received the wand (serial no. (b)(4)) back from the dental office for engineering analysis. Safety testing was performed and the wand was found to be within safety limits and specification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005174370-2016-00070 |
| MDR Report Key | 5766702 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-07-01 |
| Date of Report | 2016-09-12 |
| Date of Event | 2015-09-11 |
| Date Mfgr Received | 2015-09-12 |
| Date Added to Maude | 2016-07-01 |
| 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 | DENTAL ASSISTANT |
| 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 | 2016-07-01 |
| Returned To Mfg | 2016-08-09 |
| Catalog Number | 75030 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2016-07-01 |