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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIRONA DENTAL SYSTEMS GMBH MIDWEST E PRO 1:5 HIGH SPEED CONTRA ANGLE ATTACHMENT; HANDPIECE, AIR-POWERED, DENTAL
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SIRONA DENTAL SYSTEMS GMBH MIDWEST E PRO 1:5 HIGH SPEED CONTRA ANGLE ATTACHMENT; HANDPIECE, AIR-POWERED, DENTAL Back to Search Results
Catalog Number 875105
Device Problem Overheating of Device (1437)
Patient Problems Burn(s) (1757); No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Additional serial numbers included in this report: (b)(4).12 of 28 devices were returned for evaluation.We are awaiting the return of 16 devices.Evaluation of 10 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 customers.Evaluation of 2 devices found excessive wear due to a lack of proper maintenance.The devices did heat up during evaluation.The devices were repaired and returned to the customers.
 
Event Description
This report summarizes 28 malfunction events where a midwest e pro handpiece overheated.In two events, patient's experienced a minor burn, no intervention was required.In 26 of the events, no injury resulted.
 
Manufacturer Narrative
The information in field d3 was inadvertently missed during the initial submission.This submission is to correct the report to include this additional information.
 
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Brand Name
MIDWEST E PRO 1:5 HIGH SPEED CONTRA ANGLE ATTACHMENT
Type of Device
HANDPIECE, AIR-POWERED, DENTAL
Manufacturer (Section D)
SIRONA DENTAL SYSTEMS GMBH
fabrikstrasse 31
bensheim, hessen D-646 25
GM  D-64625
MDR Report Key11758351
MDR Text Key251732391
Report Number9614977-2021-00002
Device Sequence Number1
Product Code EFB
Combination Product (y/n)N
PMA/PMN Number
K972436
Number of Events Reported28
Summary Report (Y/N)Y
Report Source Manufacturer
Type of Report Initial,Followup
Report Date 06/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator No Information
Device Catalogue Number875105
Device Lot Number7059, 20074, 3550, 3479, 3569
Patient Sequence Number1
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