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U.S. Department of Health and Human Services

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

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KAVO DENTAL / KAVO DO BRASIL IND. COM. LTDA. MULTIFLEX COUPLING HANDPIECE, AIR POWERED, DENTAL Back to Search Results
Model Number 0.553.1390
Device Problem Device Reprocessing Problem (1091)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/25/2019
Event Type  Injury  
Event Description
The mfrs advise against reprocessing for the current detachable couplers within our unit. However the fda and the cdc state, "if an item can be detached from the dental unit, it should be reprocessed. Matters on this issue are being discussed until transition to couplers that can be reprocessed. (b)(6).
 
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Brand NameMULTIFLEX COUPLING
Type of DeviceHANDPIECE, AIR POWERED, DENTAL
Manufacturer (Section D)
KAVO DENTAL / KAVO DO BRASIL IND. COM. LTDA.
MDR Report Key8692805
MDR Text Key147944380
Report NumberMW5087303
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 Dental Assistant
Type of Report Initial
Report Date 03/26/2019
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received06/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number0.553.1390
Device Catalogue NumberMidwest
Device Lot Number1059491
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? Yes
Type of Device Usage

Patient Treatment Data
Date Received: 06/12/2019 Patient Sequence Number: 1
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