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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY DETREY GMBH DYRACT AP RESTORATIVE MATERIAL, TOOTH SHADE, RESIN

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DENTSPLY DETREY GMBH DYRACT AP RESTORATIVE MATERIAL, TOOTH SHADE, RESIN Back to Search Results
Catalog Number 60604603
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Hypersensitivity/Allergic reaction (1907); Reaction (2414)
Event Date 12/01/2015
Event Type  Injury  
Manufacturer Narrative
While it is unknown if the device used in this case caused or contributed to the patient's symptoms, it is possible as allergic reactions to dental materials are known and reported, with medical consequences being dependent upon the severity of the individual allergic response and subsequent exposure to the same material. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not been returned as of this report. Evaluation results will be submitted as they become available.
 
Event Description
A bfarm report was received indicating that a patient experienced an allergic reaction to dyract ap. Further details regarding symptoms, treatment or allergy testing are not yet available.
 
Manufacturer Narrative
Multiple unsuccessful attempts were made to obtain the device for evaluation. The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.
 
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Brand NameDYRACT AP RESTORATIVE
Type of DeviceMATERIAL, TOOTH SHADE, RESIN
Manufacturer (Section D)
DENTSPLY DETREY GMBH
detrey strasse 1
konstanz, 78467
GM 78467
Manufacturer (Section G)
DENTSPLY DETREY GMBH
detrey strasse 1
konstanz, 78467
GM 78467
Manufacturer Contact
helen lewis
221 w. philadelphia st.
suite 60w
york, PA 17401
7178494229
MDR Report Key5552604
MDR Text Key42034516
Report Number8010638-2016-00001
Device Sequence Number1
Product Code EBF
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K973235
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/07/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number60604603
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/16/2016
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 Unkown

Patient Treatment Data
Date Received: 04/06/2016 Patient Sequence Number: 1
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