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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY DETREY GMBH PRIME&BOND ACTIVE; AGENT, TOOTH BONDING, RESIN

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DENTSPLY DETREY GMBH PRIME&BOND ACTIVE; AGENT, TOOTH BONDING, RESIN Back to Search Results
Catalog Number 606.67.340
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Hypersensitivity/Allergic reaction (1907)
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.This report is for the first doctor.A dhr review was conducted with no discrepancies noted.
 
Event Description
It was reported that three doctors experienced an allergic reaction while using prime & bond active.Symptoms include itchiness, red eyes and a rash.
 
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Brand Name
PRIME&BOND ACTIVE
Type of Device
AGENT, TOOTH BONDING, 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
karl nittinger
221 w. philadelphia st.
suite 60w
york, PA 17401
7178494424
MDR Report Key8427216
MDR Text Key139037569
Report Number8010638-2019-00002
Device Sequence Number1
Product Code KLE
Combination Product (y/n)N
Reporter Country CodeEN
PMA/PMN Number
K181476
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 03/16/2019
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? Yes
Device Operator Health Professional
Device Catalogue Number606.67.340
Device Lot Number1710000531
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/14/2019
Initial Date FDA Received03/16/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
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