START-X TIP A066000000300

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other report with the FDA on 2020-03-11 for START-X TIP A066000000300 manufactured by Dentsply Maillefer.

Event Text Entries

[185719972] There has been a previous report received with a similar device where this malfunction resulted in a serious injury. Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such. As such, this event is reportable per 21cfr part 803. 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. The device was not returned for evaluation. However, the lot number was provided and retained-product testing and/or dhr review are planned. The results will be submitted as they become available.
Patient Sequence No: 1, Text Type: N, H10


[185719973] In this event it was reported that a start-x tip broke. The event outcome is unknown as of this mdr evaluation.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8031010-2020-00034
MDR Report Key9821937
Report SourceFOREIGN,OTHER
Date Received2020-03-11
Date of Report2020-03-11
Date Mfgr Received2020-02-10
Date Added to Maude2020-03-11
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
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
Manufacturer CountryUS
Manufacturer Phone8494424
Manufacturer G1DENTSPLY MAILLEFER
Manufacturer StreetCHEMIN DU VERGER 3
Manufacturer CityBALLAIGUES, 1338
Manufacturer CountrySZ
Manufacturer Postal Code1338
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSTART-X TIP
Generic NameSCALER, ULTRASONIC
Product CodeELC
Date Received2020-03-11
Model NumberNA
Catalog NumberA066000000300
Lot Number1365834
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDENTSPLY MAILLEFER
Manufacturer AddressCHEMIN DU VERGER 3 BALLAIGUES, 1338 SZ 1338


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-11

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