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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W&H IMPEX WS-75, HANDPIECE - DU900

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W&H IMPEX WS-75, HANDPIECE - DU900 Back to Search Results
Catalog Number DU9WS75
Device Problem Mechanical Problem (1384)
Patient Problem No Information (3190)
Event Date 01/17/2018
Event Type  Injury  
Event Description
The doctor reported that the handpiece (du9ws75) malfunctioned and that he was unable to complete the procedure. The patient will return at a later date.
 
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Brand NameWS-75, HANDPIECE - DU900
Type of DeviceHANDPIECE
Manufacturer (Section D)
W&H IMPEX
14300 henn street
dearborn MI 48126
MDR Report Key7244198
MDR Text Key99128119
Report Number0001038806-2018-00088
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 02/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other Health Care Professional
Device Catalogue NumberDU9WS75
Device Lot Number11601
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/30/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date01/17/2018
Event Location Other
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 02/06/2018 Patient Sequence Number: 1
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