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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KAVO DO BRASIL IND. COM. LTDA. MULTIFLEX LUX COUPLING MIDWEST DENTAL COUPLER HANDPIECE, AIR POWERED

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KAVO DO BRASIL IND. COM. LTDA. MULTIFLEX LUX COUPLING MIDWEST DENTAL COUPLER HANDPIECE, AIR POWERED Back to Search Results
Lot Number 0.553.1390
Device Problem Failure to Clean Adequately (4048)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
Dental coupling device ifus state that external chemical disinfection (wiping, not immersion) is all that is needed between patients. Per the dental evaluation and consultation service, fda and cdc guidance states that dental coupling devices should be sterilized between patients.
 
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Brand NameMULTIFLEX LUX COUPLING MIDWEST
Type of DeviceDENTAL COUPLER HANDPIECE, AIR POWERED
Manufacturer (Section D)
KAVO DO BRASIL IND. COM. LTDA.
MDR Report Key8459638
MDR Text Key140440915
Report NumberMW5085233
Device Sequence Number1
Product Code EFB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/25/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/27/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number0.553.1390
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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