MIDWEST E PLUS 1:5 HIGHSPEED ATTACHMENT 875205

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-04-12 for MIDWEST E PLUS 1:5 HIGHSPEED ATTACHMENT 875205 manufactured by Sirona Dental Systems Gmbh.

Event Text Entries

[141763739] While no serious injury resulted in this event, there has been a previous report received 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. Handpiece didnt get hot. Handpiece failed specs due to cap sticking coming intact with rotor. Cap has white paste/debris on side of cap cause the cap to stick inwards position when pressed.
Patient Sequence No: 1, Text Type: N, H10


[141763740] It was reported that a midwest e plus 1:5 ca overheated during use and burned a patient's cheek; no intervention was required.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9614977-2019-00049
MDR Report Key8508996
Report SourceHEALTH PROFESSIONAL
Date Received2019-04-12
Date of Report2019-04-05
Date Added to Maude2019-04-12
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationDENTIST
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 17401
Manufacturer CountryUS
Manufacturer Postal17401
Manufacturer Phone7178494424
Manufacturer G1SIRONA DENTAL SYSTEMS GMBH
Manufacturer StreetFABRIKSTRASSE 31
Manufacturer CityBENSHEIM, HESSEN D-64625
Manufacturer CountryGM
Manufacturer Postal CodeD-64625
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMIDWEST E PLUS 1:5 HIGHSPEED ATTACHMENT
Generic NameHANDPIECE, BELT AND/OR GEAR DRIVEN, DENTAL
Product CodeEFA
Date Received2019-04-12
Returned To Mfg2019-03-15
Model NumberNA
Catalog Number875205
Lot NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSIRONA DENTAL SYSTEMS GMBH
Manufacturer AddressFABRIKSTRASSE 31 BENSHEIM, D-64625 GM D-64625


Patients

Patient NumberTreatmentOutcomeDate
10 2019-04-12

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