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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 Problem Vibration (1674)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/23/2016
Event Type  Malfunction  
Event Description

It was reported the device constantly vibrates.

 
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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 dr.
austin, TX 78735
MDR Report Key6973679
MDR Text Key90795474
Report Number1643264-2017-00962
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
Type of Report Initial
Report Date 10/24/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/24/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number72200616S
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/23/2016
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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