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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MOTOR DRIVE UNIT, HAND CNTRL, PWRMX EL SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. MOTOR DRIVE UNIT, HAND CNTRL, PWRMX EL SAW, POWERED, AND ACCESSORIES Back to Search Results
Model Number 72200616
Device Problem Overheating of Device (1437)
Patient Problems Burn, Thermal (2530); Partial thickness (Second Degree) Burn (2694)
Event Date 02/02/2018
Event Type  Injury  
Event Description

It was reported that the cable of the powermax handpiece has overheated and has caused a second degree burn to the patient.

 
Manufacturer Narrative

The reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed. No relevant supporting clinical/medical information or photos have been provided; therefore a thorough clinical analysis cannot be rendered. A relationship, if any, between the subject device and the reported event could not be determined.

 
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Brand NameMOTOR DRIVE UNIT, HAND CNTRL, PWRMX EL
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 west william cannon drive
austin, TX 78735
MDR Report Key7318609
MDR Text Key101670916
Report Number1643264-2018-00196
Device Sequence Number1
Product Code HAB
Combination Product (Y/N)N
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN,HEALTH PR
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/25/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/06/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number72200616
Device Catalogue Number72200616
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/23/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 03/06/2018 Patient Sequence Number: 1
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