PRIME & BOND NT 606.67.240

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2018-11-02 for PRIME & BOND NT 606.67.240 manufactured by Dentsply Detrey Gmbh.

Event Text Entries

[126062686] 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 fourth patient. The device was evaluated and found to be within specification.
Patient Sequence No: 1, Text Type: N, H10


[126062687] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8010638-2018-00011
MDR Report Key8035613
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2018-11-02
Date of Report2018-11-02
Date Mfgr Received2018-10-04
Date Added to Maude2018-11-02
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationDENTIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. KARL NITTINGER
Manufacturer Street221 W. PHILADELPHIA ST. SUITE 60W
Manufacturer CityYORK PA 17401
Manufacturer CountryUS
Manufacturer Postal17401
Manufacturer Phone7178494424
Manufacturer G1DENTSPLY DETREY GMBH
Manufacturer StreetDETREY STRASSE 1
Manufacturer CityKONSTANZ, 78467
Manufacturer CountryGM
Manufacturer Postal Code78467
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePRIME & BOND NT
Generic NameAGENT, TOOTH BONDING, RESIN
Product CodeKLE
Date Received2018-11-02
Returned To Mfg2018-10-15
Model NumberNA
Catalog Number606.67.240
Lot Number1801000924
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerDENTSPLY DETREY GMBH
Manufacturer AddressDETREY STRASSE 1 KONSTANZ, 78467 GM 78467


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-11-02

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.