MIDWEST STYLUS ATC HANDPIECE 882300

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-28 for MIDWEST STYLUS ATC HANDPIECE 882300 manufactured by Sirona Dental Systems Gmbh.

Event Text Entries

[184714099] 1 of 1 device was returned for evaluation. Evaluation of the one returned device found excessive wear due to a lack of proper maintenance. This device did heat up during evaluation. The device was repaired and returned to the customer.
Patient Sequence No: 1, Text Type: N, H10


[184714100] This report summarizes 1 malfunction events. This report summarizes one malfunction event where a midwest stylus atc mini handpiece overheated during use; no injury resulted.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9614977-2019-00165
MDR Report Key9639598
Date Received2020-01-28
Date of Report2020-01-28
Date Added to Maude2020-01-28
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
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 G1SIRONA DENTAL SYSTEMS GMBH
Manufacturer StreetFABRIKSTRASSE 31
Manufacturer CityBENSHEIM, D-64625
Manufacturer CountryGM
Manufacturer Postal CodeD-64625
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMIDWEST STYLUS ATC HANDPIECE
Generic NameHANDPIECE, AIR-POWERED, DENTAL
Product CodeEFB
Date Received2020-01-28
Model NumberNA
Catalog Number882300
Lot NumberNA
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerSIRONA DENTAL SYSTEMS GMBH
Manufacturer AddressFABRIKSTRASSE 31 BENSHEIM, D-64625 GM D-64625


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-28

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