PROVIL NOVO L 65210096

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 2017-05-02 for PROVIL NOVO L 65210096 manufactured by Heraeus Kulzer Srl.

Event Text Entries

[74168506] This occurred in (b)(6). As allowed by exemption # (b)(4), (b)(4) (the importer) is submitting the report on behalf of (b)(4) (the manufacturer). Although we have not established that the device caused or contributed to the event, we're reporting it to be compliant with 21 cfr part 803 and out of an abundance of caution. Narrative for section h6 method, results and conclusions codes the device has not been returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10


[74168507] A (b)(6) male patient had itching and burning sensation in mouth after use of provo novil. Has history of allergic reactions. Allergy medication was administered, although this product contains no peppermint oil.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3011203516-2017-00002
MDR Report Key6536618
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2017-05-02
Date of Report2017-04-03
Date of Event2017-03-29
Date Mfgr Received2017-04-03
Date Added to Maude2017-05-02
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 ContactMS. RITA ROGERS
Manufacturer Street300 HERAEUS WAY
Manufacturer CitySOUTH BEND IN 46614
Manufacturer CountryUS
Manufacturer Postal46614
Manufacturer Phone5742995409
Manufacturer G1HERAEUS KULZER SRL
Manufacturer StreetCLADERIA C3 DIETRCH HONOLD 1
Manufacturer CitySACALAZ-JUDETUL, TIMIS 307370
Manufacturer CountryRO
Manufacturer Postal Code307370
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePROVIL NOVO L
Generic NameMATERIAL, IMPRESSION
Product CodeELW
Date Received2017-05-02
Catalog Number65210096
Lot NumberR010023
Device Expiration Date2019-10-20
OperatorDENTIST
Device Availability*
Device Age6 MO
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerHERAEUS KULZER SRL
Manufacturer AddressCLADERIA C3 DIETRCH HONOLD 1 SACALAZ-JUDETUL, TIMIS 307370 RO 307370


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2017-05-02

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