3M TRUE DEFINITION SCANNER 78007

MAUDE Adverse Event Report

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.

Event Text Entries

[53277932] 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 english and italian) 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)(6) holiday ((b)(6) 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


[53277933] On (b)(6) 2016, 3m learned that during the use of a 3m true definition scanner, an (b)(6) year-old female patient experienced an electrical sensation/shock when the scanning wand touched her teeth. This event occurred in italy 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


[57962832] (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


MAUDE Entry Details

Report Number3005174370-2016-00089
MDR Report Key5909169
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2016-08-26
Date of Report2016-09-26
Date of Event2016-07-27
Date Mfgr Received2016-09-26
Date Added to Maude2016-08-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Manufacturer ContactANGIE DRAPER
Manufacturer Street2510 CONWAY AVENUE
Manufacturer CityST. PAUL MN 551441000
Manufacturer CountryUS
Manufacturer Postal551441000
Manufacturer Phone6517331179
Manufacturer G13M ESPE DENTAL PRODUCTS
Manufacturer Street2510 CONWAY AVENUE
Manufacturer CityST. PAUL MN 551441000
Manufacturer CountryUS
Manufacturer Postal Code551441000
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name3M TRUE DEFINITION SCANNER
Generic NameSYSTEM,OPTICAL IMPRESSION, COMPUTER ASSISTED DESIGN AND MANUFACTURING (CAD/CAM)
Product CodeNOF
Date Received2016-08-26
Catalog Number78007
OperatorDENTIST
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
Manufacturer3M ESPE DENTAL PRODUCTS
Manufacturer Address2510 CONWAY AVENUE ST. PAUL MN 551441000 US 551441000


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2016-08-26

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