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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY DETREY GMBH PRIME&BOND XP; AGENT, TOOTH BONDING, RESIN
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DENTSPLY DETREY GMBH PRIME&BOND XP; AGENT, TOOTH BONDING, RESIN Back to Search Results
Catalog Number 606.67.281
Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Caustic/Chemical Burns (2549)
Event Type  Injury  
Manufacturer Narrative
Therefore, because this event resulted in medical intervention, it is reportable per 21cfr 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 a chemical burn after a dental adhesive product, prime and bond xp, inadvertently came into contact with soft tissue.The doctor prescribed a mild steroid and burn ointment to the patient.
 
Manufacturer Narrative
Multiple unsuccessful attempts were made to obtain the device for evaluation.A dhr review was conducted with no discrepancies noted.
 
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Brand Name
PRIME&BOND XP
Type of Device
AGENT, TOOTH BONDING, RESIN
Manufacturer (Section D)
DENTSPLY DETREY GMBH
detrey strasse 1
konstanz, 78467
GM  78467
MDR Report Key8166620
MDR Text Key130459432
Report Number8010638-2018-00014
Device Sequence Number1
Product Code KLE
Combination Product (y/n)N
PMA/PMN Number
K070538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 02/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number606.67.281
Device Lot Number1708000100
Was Device Available for Evaluation? Yes
Date Manufacturer Received01/07/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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