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 2016-08-26 for 3M TRUE DEFINITION SCANNER 78007 manufactured by 3m Espe Dental Products.
[53277710]
Appropriate electrical safety measures (isolation transformer) are present in the true definition scanner system. The 3m true definition scanner user manual and instructions for use (ifu) (available in (b)(4)) contain the following: "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. ' a third party site assessment is planned to take place after the (b)(4) holiday (august 31, 2016). 3m may also be provided with a copy of the latest yearly power socket assessment. Any additional information that becomes available will be submitted by 3m in a follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[53277711]
On (b)(6) 2016, 3m learned that during the use of a 3m true definition scanner, an (b)(6) year-old male patient experienced an electrical sensation/shock when the scanning wand touched his teeth. This event occurred in (b)(6) and during the scan in which the electrical sensation/shock occurred, the dentist reported that the true definition scanner was plugged into an extension cord.
Patient Sequence No: 1, Text Type: D, B5
[58052518]
(b)(4) received an electrical safety inspection report from the dentist which stated that the dental chair was found to have no functional defects or deficiencies that were safety-related. No further complaints have been reported by the dental office since they discontinued use of the extension cord with the true definition scanner.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005174370-2016-00087 |
| MDR Report Key | 5909134 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-08-26 |
| Date of Report | 2016-09-26 |
| Date of Event | 2016-07-27 |
| Date Mfgr Received | 2016-09-26 |
| Date Added to Maude | 2016-08-26 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| 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 | 2016-08-26 |
| Catalog Number | 78007 |
| Operator | DENTIST |
| Device Availability | Y |
| 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 | 2016-08-26 |