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

Catalog Number 606.67.240

Device Problem Device Handling Problem (3265)

Patient Problem Caustic/Chemical Burns (2549)

Event Type  Injury  

Manufacturer Narrative

Follow-up with the doctor determined that an error in their technique may have caused the chemical burns.During application of the prime & bond nt on a brush (instead of the applicator tip), a possible contamination of the gloves was described by the doctor.Furthermore, it was observed that the burns always occurred on the side of the treating dentist that typically would stabilize instruments by touching the site of burn with their gloved fingers.The dfu clearly warns users to avoid skin contact and gives instructions for what to do if skin contact is made.Since a serious injury resulted, this event is reportable per 21 cfr part 803.This report if for the second patient.The device was evaluated and found to be within specification.

Event Description

In this event a doctor reported that he had four pediatric patients that were all treated with prime & bond nt and all four patient's had a chemical burn on the outside right corner of their mouths after treatment.

• Brand Name: PRIME & BOND NT
• 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 Key: 8035618
• MDR Text Key: 126065955
• Report Number: 8010638-2018-00009
• Device Sequence Number: 1
• Product Code: KLE
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K982394
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 11/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2020
• Device Catalogue Number: 606.67.240
• Device Lot Number: 1801000924
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other