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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KAVO DENTAL GMBH KAVO MULTIFLEX COUPLING 453N HANDPIECE, AIR-POWERED, DENTAL

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KAVO DENTAL GMBH KAVO MULTIFLEX COUPLING 453N HANDPIECE, AIR-POWERED, DENTAL Back to Search Results
Model Number 453 N
Device Problem Problem with Sterilization (1596)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
Couplers are non-sterilizable according to mfr ifu.
 
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Brand NameKAVO MULTIFLEX COUPLING 453N
Type of DeviceHANDPIECE, AIR-POWERED, DENTAL
Manufacturer (Section D)
KAVO DENTAL GMBH
bismarckring 39d
biberach 88400
MDR Report Key8496920
MDR Text Key141500592
Report NumberMW5085687
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 Dentist
Type of Report Initial
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/08/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number453 N
Device Lot Number0.553.1620
Was Device Available for Evaluation? No Answer Provided
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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