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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: 3M ESPE DENTAL PRODUCTS 3M ESPE FILTEK BULK FILL POSTERIOR RESTORATIVE; MATERIAL, TOOTH SHADE, RESIN
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3M ESPE DENTAL PRODUCTS 3M ESPE FILTEK BULK FILL POSTERIOR RESTORATIVE; MATERIAL, TOOTH SHADE, RESIN Back to Search Results
Catalog Number 4863B1
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 06/30/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This event involved two 3m products; therefore, two manufacturer reports are being submitted.This report represents the first product.Manufacturer report 9611385-2017-00009 represents the second product.
 
Event or Problem Description
On (b)(6) 2017, 3m was notified that a (b)(6) female patient required root canal treatment on tooth #28 following a dental treatment with 3m espe filtek bulk fill posterior restorative and 3m espe elipar deep cure-s led curing lite.
 
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Brand Name
3M ESPE FILTEK BULK FILL POSTERIOR RESTORATIVE
Common Device Name
MATERIAL, TOOTH SHADE, RESIN
Manufacturer (Section D)
3M ESPE DENTAL PRODUCTS
2510 conway avenue
st. paul MN 55144 1000
MDR Report Key6723753
Report Number3005174370-2017-00042
Device Sequence Number16544619
Product Code EBF
UDI-Device Identifier30605861000414
UDI-Public(01)30605861000414
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
K141081
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 07/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Dentist
Device Catalogue Number4863B1
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/07/2017
Initial Report FDA Received Date07/18/2017
Patient Sequence Number1
Outcome Attributed to Adverse Event Other; Required Intervention;
Patient Age73 YR
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