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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SERVICE REP,MINI,MDU EP-1 SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. SERVICE REP,MINI,MDU EP-1 SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 7205357S
Device Problem Self-Activation or Keying (1557)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Manufacturer Narrative

Foreign zip code: (b)(6).

 
Event Description

It was reported that before the surgery the blade moved a little after the unit was off. No patient involved.

 
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Brand NameSERVICE REP,MINI,MDU EP-1
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
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key8746170
MDR Text Key149570949
Report Number1643264-2019-00433
Device Sequence Number1
Product Code HAB
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/31/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/28/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number7205357S
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 Received07/30/2019
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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