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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: 3M DEUTSCHLAND GMBH 3M ESPE ELIIPAR DEEPCURE-S LED CURING LIGHT; ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION

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3M DEUTSCHLAND GMBH 3M ESPE ELIIPAR DEEPCURE-S LED CURING LIGHT; ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION Back to Search Results
Model Number 76976
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Code Available (3191)
Event Date 06/30/2017
Event Type  Injury  
Manufacturer Narrative
This event involved two 3m products; therefore, two manufacturer reports are being submitted.This report represents the second product.Manufacturer report 3005174370-2017-00042 represents the first product.
 
Event 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 ELIIPAR DEEPCURE-S LED CURING LIGHT
Type of Device
ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION
Manufacturer (Section D)
3M DEUTSCHLAND GMBH
carl-schurz-strasse 1
neuss, 41453
GM  41453
Manufacturer (Section G)
3M DEUTSCHLAND GMBH-SEEFELD
espe platz
seefeld, 82229
GM   82229
Manufacturer Contact
thomas meindl
carl-schurz-strasse 1
neuss, 41453
GM   41453
MDR Report Key6723564
MDR Text Key80379718
Report Number9611385-2017-00009
Device Sequence Number1
Product Code EBZ
UDI-Device IdentifierJ001702011438670
UDI-Public+J001702011438670
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K011154
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Dentist
Type of Report Initial
Report Date 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
Device Operator Dentist
Device Model Number76976
Device Catalogue Number76976
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/07/2017
Initial Date FDA Received07/18/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age73 YR
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