PRIME & BOND ACTIVE 606.67.345

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 2018-03-16 for PRIME & BOND ACTIVE 606.67.345 manufactured by Dentsply Detrey Gmbh.

Event Text Entries

[102704113] 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 patient. Please note that while this product is not sold in the us, it is considered similar to products that are marketed in the us by dentsply sirona. The device was evaluated and found to be within specification. A dhr review was conducted with no discrepancies noted.
Patient Sequence No: 1, Text Type: N, H10


[102704114] It was reported that a dentist used prime & bond active on two patients and within 10 minutes after treatment, their skin burned and their lips were swollen.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8010638-2018-00001
MDR Report Key7346121
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2018-03-16
Date of Report2018-03-16
Date of Event2018-02-13
Date Mfgr Received2018-02-16
Date Added to Maude2018-03-16
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 ContactMRS. HELEN LEWIS
Manufacturer Street221 W. PHILADELPHIA ST. SUITE 60W
Manufacturer CityYORK PA 17401
Manufacturer CountryUS
Manufacturer Postal17401
Manufacturer Phone7178494229
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 ACTIVE
Generic NameAGENT, TOOTH BONDING, RESIN
Product CodeKLE
Date Received2018-03-16
Returned To Mfg2018-02-26
Model NumberNA
Catalog Number606.67.345
Lot Number1704000549
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 2018-03-16

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