MIDWEST E PRO 1:5 875105

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 E PRO 1:5 875105 manufactured by Sirona Dental Systems Gmbh.

Event Text Entries

[184707253] Additional serial numbers included in this report: (b)(4). 18 of 18 devices were returned for evaluation. Evaluation of two returned devices found excessive wear due to a lack of proper maintenance. There was also evidence of debris build-up. The devices did not heat up during evaluation. The devices were repaired and returned to the customer. Evaluation of one returned device found excessive wear due to a lack of proper maintenance. There was also a lack of lubrication and evidence of debris build-up. This device did heat up during evaluation. The device was repaired and returned to the customer. Evaluation of three returned devices found excessive wear due to a lack of proper maintenance. The devices did not heat up during evaluation. The devices were repaired and returned to the customer. Evaluation of 12 returned devices found excessive wear due to a lack of proper maintenance. There was also evidence of debris build-up. The devices did not heat up during evaluation. The devices were repaired and returned to the customer.
Patient Sequence No: 1, Text Type: N, H10


[184707254] This report summarizes 18 malfunction events. This report summarizes 18 malfunction event where a midwest e pro 1:5 handpiece overheated during use. In five events, patient's were burned, but they did not require any intervention to treat the minor burn. In 13 events, there were no injuries.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9614977-2019-00163
MDR Report Key9639597
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 E PRO 1:5
Generic NameHANDPIECE, AIR-POWERED, DENTAL
Product CodeEFB
Date Received2020-01-28
Model NumberNA
Catalog Number875105
Lot NumberNA
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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