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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIRONA DENTAL SYSTEMS GMBH MIDWEST E MINI 1:5 HIGH SPEED CONTRA ANGLE ATTACHMENT; HANDPIECE, AIR-POWERED, DENTAL

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SIRONA DENTAL SYSTEMS GMBH MIDWEST E MINI 1:5 HIGH SPEED CONTRA ANGLE ATTACHMENT; HANDPIECE, AIR-POWERED, DENTAL Back to Search Results
Catalog Number 792301
Device Problem Overheating of Device (1437)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
This report summarizes 2 malfunction events where a midwest e mini handpiece overheated.No injury resulted in any of the events.
 
Manufacturer Narrative
2 of 2 devices were returned for evaluation.Evaluation of two devices found excessive wear due to a lack of proper maintenance.The devices did not heat up during evaluation.The devices had debris build-up.The devices were repaired and returned to the customers.
 
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Brand Name
MIDWEST E MINI 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
Manufacturer (Section G)
SIRONA DENTAL SYSTEMS GMBH
fabrikstrasse 31
bensheim, hessen D-646 25
GM   D-64625
Manufacturer Contact
hannah seevaratnam
221 w. philadelphia st.
suite 60w
york, PA 17401
7178494593
MDR Report Key14219424
MDR Text Key290190927
Report Number9614977-2022-00010
Device Sequence Number1
Product Code EFB
Combination Product (y/n)N
PMA/PMN Number
K972436
Number of Events Reported2
Summary Report (Y/N)Y
Report Source Manufacturer
Reporter Occupation Other
Type of Report Initial
Report Date 04/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue Number792301
Patient Sequence Number1
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