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

Catalog Number 66801253

Device Problem Obstruction of Flow (2423)

Patient Problem Injury (2348)

Event Date 06/04/2020

Event Type  Injury  

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.

• Brand Name: RENASYS 15 FR CHANNEL DRAIN A KIT
• Type of Device: MESH, 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 Key: 10237898
• MDR Text Key: 197743694
• Report Number: 8043484-2020-01712
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (Y/N): N
• Reporter Country Code: GM
• PMA/PMN Number: K112784
• Number of Events Reported: 1
• 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 Received: 07/06/2020
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: NO INFORMATION
• Device Catalogue Number: 66801253
• Device LOT Number: UNKNOWN
• 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 Received: 10/01/2020
• 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