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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVC REPL,MDU, HAND CNTRL, PWRMX SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. SVC REPL,MDU, HAND CNTRL, PWRMX SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 72200616S
Device Problems Overheating of Device (1437); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
It was reported the powermax mdu hand control got hot and stopped. No injuries or complications were reported as a result.
 
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Brand NameSVC REPL,MDU, HAND CNTRL, PWRMX
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 drive
austin, TX 78735
MDR Report Key6659022
MDR Text Key78250588
Report Number1643264-2017-00351
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial
Report Date 06/21/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/21/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number72200616S
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/08/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/15/2016
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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