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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: 3M ESPE DENTAL PRODUCTS 3M ESPE FILTEK SUPREME ULTRA UNIVERSAL RESTORATIVE; MATERIAL, TOOTH SHADE, RESIN

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3M ESPE DENTAL PRODUCTS 3M ESPE FILTEK SUPREME ULTRA UNIVERSAL RESTORATIVE; MATERIAL, TOOTH SHADE, RESIN Back to Search Results
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
A follow-up interview by 3m showed a high probability that disregard of the instructions for use may have led to these adverse events.The dentist appears to have overdried during the application, which subsequently may have resulted in the pulpitic sensitivities.
 
Event Description
On (b)(6) 2016, it was reported to 3m that a dentist had several cases of sensitivity that led to root canal treatment following dental treatment with 3m espe filtek supreme xte universal restorative (also known as filtek supreme ultra universal restorative).The dentist didn't provide any further information about the number of patients involved or the number of root canals performed.
 
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Brand Name
3M ESPE FILTEK SUPREME ULTRA UNIVERSAL RESTORATIVE
Type of Device
MATERIAL, TOOTH SHADE, RESIN
Manufacturer (Section D)
3M ESPE DENTAL PRODUCTS
2510 conway avenue
st. paul MN 55144 1000
Manufacturer (Section G)
3M ESPE DENTAL PRODUCTS
2510 conway avenue
st. paul MN 55144 1000
Manufacturer Contact
angie draper
2510 conway avenue
st. paul, MN 55144-1000
6517331179
MDR Report Key6205110
MDR Text Key63310545
Report Number3005174370-2016-00160
Device Sequence Number1
Product Code EBF
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K083610
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Dentist
Type of Report Initial
Report Date 12/05/2016
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/05/2016
Initial Date FDA Received12/27/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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