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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. RENASYS 15 FR CHANNEL DRAIN A KIT MESH, SURGICAL, POLYMERIC

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SMITH & NEPHEW MEDICAL LTD. RENASYS 15 FR CHANNEL DRAIN A KIT MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number 66801253
Device Problem Obstruction of Flow (2423)
Patient Problem Injury (2348)
Event Date 06/04/2020
Event Type  Malfunction  
Event Description

It was reported that the problem occurred only with the drainage kit and not the gauze drainage kit but the corresponding part number was given. During the course of the treatment in the anal area with canal drainage, both the touch pump and the go pump repeatedly displayed blockage alarms with the drainage. Due to the frequent alarm, the patient suffered from wound healing disorders and the findings worsened. This led to several additional operating theaters and a longer hospital stay. The problem lies on the t-vent of the drainage.

 
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Brand NameRENASYS 15 FR CHANNEL DRAIN A KIT
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
SMITH & NEPHEW MEDICAL LTD.
101 hessle road
hull east riding of yorkshire HU3 2 BN
UK HU3 2BN
Manufacturer (Section G)
SMITH & NEPHEW MEDICAL LTD.
101 hessle road
hull east riding of yorkshire HU3 2 BN
UK HU3 2BN
Manufacturer Contact
sarah freestone
101 hessle road
hull east riding of yorkshire HU3 2-BN
UK   HU3 2BN
0447940038
MDR Report Key10237901
MDR Text Key197742978
Report Number8043484-2020-01713
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeGM
PMA/PMN NumberK112784
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/05/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/06/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device Catalogue Number66801253
Device LOT NumberUNKNOWN
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 Received10/01/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/06/2020 Patient Sequence Number: 1
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