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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W&H DENTALWERK WS-75, HANDPIECE - DU900 HAND PIECE

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W&H DENTALWERK WS-75, HANDPIECE - DU900 HAND PIECE Back to Search Results
Catalog Number DU9WS75
Device Problem Mechanical Problem (1384)
Patient Problem No Information (3190)
Event Type  Injury  
Event Description
It was reported that a hand piece (du9ws75) did not spin while in use. Procedure could not be completed.
 
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Brand NameWS-75, HANDPIECE - DU900
Type of DeviceHAND PIECE
Manufacturer (Section D)
W&H DENTALWERK
6490 hawthorne drive
windsor, ontario N8T 1 J9
CA N8T 1J9
MDR Report Key8523251
MDR Text Key142230644
Report Number0001038806-2019-00330
Device Sequence Number1
Product Code EKX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberDU9WS75
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date03/18/2019
Event Location Other
Date Report to Manufacturer04/17/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 04/17/2019 Patient Sequence Number: 1
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