AH PLUS JET 60620118

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 2015-09-29 for AH PLUS JET 60620118 manufactured by Dentsply Detrey Gmbh.

Event Text Entries

[27052157] Therefore, because intervention was required, this event is reportable per 21 cfr part 803. The device is available for evaluation, though results are not available as of this report. Evaluation results will be submitted as they become available.
Patient Sequence No: 1, Text Type: N, H10


[27052158] It was reported that after endodontic treatment with ah plus jet on tooth # 36 a patient experienced strong pain that would not yield to painkillers, nor to anti-inflammatory drugs. Once unsealing occurred, the pain disappeared. The dentist used calcium hydroxide and performed new sealing with a eugenate based cement.
Patient Sequence No: 1, Text Type: D, B5


[31097509] The device was evaluated and found to be within specification. Also, a dhr review was conducted with no discrepancies noted.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number8010638-2015-00011
MDR Report Key5111304
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2015-09-29
Date of Report2015-08-31
Date of Event2015-07-07
Date Mfgr Received2015-10-12
Date Added to Maude2015-09-29
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 NameAH PLUS JET
Generic NameRESIN, ROOT CANAL FILLING
Product CodeKIF
Date Received2015-09-29
Returned To Mfg2015-09-28
Model NumberNA
Catalog Number60620118
Lot Number1503000833
Device Expiration Date2017-02-28
OperatorDENTIST
Device AvailabilityR
Device AgeDA
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. Required No Informationntervention 2015-09-29

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