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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: 3M ESPE DENTAL PRODUCTS RELYX LUTING PLUS; DENTAL CEMENT
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3M ESPE DENTAL PRODUCTS RELYX LUTING PLUS; DENTAL CEMENT Back to Search Results
Catalog Number 3525
Device Problems Patient-Device Incompatibility (2682); Compatibility Problem (2960)
Patient Problem Burning Sensation (2146)
Event Date 08/01/2013
Event Type  Injury  
Event Description
On (b)(6) 2013 a dentist reported that in (b)(6) 2013, a crown which had been cemented with 3m (tm) espe (tm) relyx (tm) luting plus cement was removed due to a diffuse burning sensation in the pt's mouth.No intra-oral symptoms of redness or swelling were observed.Symptoms did not resolve and subsequently, the remaining tooth structure was extracted.
 
Manufacturer Narrative
This product has been evaluated for biocompatibility and found to be safe for its intended use.Further, the product has a favorable clinical usage history with no other reports of this nature made to 3m espe.
 
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Brand Name
RELYX LUTING PLUS
Type of Device
DENTAL CEMENT
Manufacturer (Section D)
3M ESPE DENTAL PRODUCTS
saint paul MN
Manufacturer Contact
angie draper
3m center bldg 275-2w-08
saint paul, MN 55144-1000
6517331179
MDR Report Key3669485
MDR Text Key4347617
Report Number3005174370-2014-00002
Device Sequence Number1
Product Code EMA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K022476
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 12/13/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/07/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number3525
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/13/2013
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Patient Sequence Number1
Patient Outcome(s) Disability;
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