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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY DETREY GMBH VISCO-GEL TISSUE TREATMENT MATERIAL RESIN, DENTURE, RELINING, REPAIRING, REBASING

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DENTSPLY DETREY GMBH VISCO-GEL TISSUE TREATMENT MATERIAL RESIN, DENTURE, RELINING, REPAIRING, REBASING Back to Search Results
Catalog Number 61605002
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Reaction (2414)
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

In this event it was reported that a patient experienced an allergic reaction to visco-gel approximately 3 to 4 hours after coming in contact with the product. The patient suffered from severe inflammation on their gums and tongue, causing her to remove the device. To date, although she did not put the device in place, inflammation persists, with the presence of canker sores on the edge of the tongue.

 
Manufacturer Narrative

Multiple unsuccessful attempts were made to obtain the device for evaluation. The device was not returned for evaluation and the lot number that was provided is not valid. Therefore, retained-product testing and/or dhr review is not possible.

 
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Brand NameVISCO-GEL TISSUE TREATMENT MATERIAL
Type of DeviceRESIN, DENTURE, RELINING, REPAIRING, REBASING
Manufacturer (Section D)
DENTSPLY DETREY GMBH
detrey strasse 1
konstanz, 78467
GM 78467
Manufacturer (Section G)
DENTSPLY CAULK
38 w. clark ave.
milford DE 19963
Manufacturer Contact
helen lewis
221 w. philadelphia st.
suite 60w
york, PA 17401
7178494229
MDR Report Key5223165
MDR Text Key31182164
Report Number2515379-2015-00072
Device Sequence Number1
Product Code EBI
Combination Product (Y/N)N
Reporter Country CodeFR
PMA/PMN NumberNA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation DENTIST
Type of Report Initial,Followup
Report Date 10/16/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/13/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/31/2017
Device Catalogue Number61605002
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/15/2016
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: 11/13/2015 Patient Sequence Number: 1
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