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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVCE REP DYONICSPOWERMINI HAND CONTROLS SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. SVCE REP DYONICSPOWERMINI HAND CONTROLS SAW, POWERED, AND ACCESSORIES Back to Search Results
Model Number 72201500S
Device Problem Connection Problem (2900)
Patient Problem No Patient Involvement (2645)
Event Date 07/20/2020
Event Type  Malfunction  
Event Description

It was reported that the dyonics power mini did not recognize the control unit. No case reported; therefore, there was no patient involvement. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.

 
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Brand NameSVCE REP DYONICSPOWERMINI HAND CONTROLS
Type of DeviceSAW, POWERED, AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107
Manufacturer (Section G)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key10515710
MDR Text Key206378353
Report Number1643264-2020-01130
Device Sequence Number1
Product Code HAB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 12/10/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/10/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number72201500S
Device Catalogue Number72201500S
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/20/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/08/2020
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 Unkown

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