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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DYONICS POWER CONTROL UNIT SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. DYONICS POWER CONTROL UNIT SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 7205841
Device Problems Device Emits Odor (1425); Smoking (1585)
Patient Problem No Information (3190)
Event Date 02/10/2015
Event Type  Malfunction  
Event Description

It was reported that the device has electrical smell and is smoking.

 
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Brand NameDYONICS POWER CONTROL UNIT
Type of DeviceSAW, POWERED, AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107 6512
Manufacturer (Section G)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107 6512
Manufacturer Contact
jim gonzales
7000 w william cannon dr.
austin, TX 78735
MDR Report Key6979486
MDR Text Key90951187
Report Number1643264-2017-01061
Device Sequence Number1
Product Code HAB
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial
Report Date 10/26/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/26/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number7205841
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/10/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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