MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. RENASYS GO; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Catalog Number 66021496

Device Problem Gas/Air Leak (2946)

Patient Problem Skin Irritation (2076)

Event Date 02/24/2020

Event Type  malfunction  

Event Description

It was reported that the renasys go placed on patient on (b)(6) continues to show leak warning no matter what was done to try and secure the dressing.Customer has changed the dressing multiple times.The patients foot is tender from all the dressing changes at this time.She also reported the skin around the wound was a little white in color and she was unsure if that was from possibly not having any drainage being pulled through.She did say the dressing is suctioned down and firm to touch but no drainage was in the canister from the last dressing change last friday, (b)(6) 2020.After trouble shooting steps the leak warning still was displaying.Customer was encouraged to contact the physician and/or hospital to request a different one since it continuously gives leak warning.Therapy continued with leak warning displayed, dressing suctioned down, firm to touch.

• Brand Name: RENASYS GO
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: sarah freestone ; 101 hessle road; hull HU3 2-BN ; UK HU3 2BN ; 0447940038
• MDR Report Key: 9860632
• MDR Text Key: 184304026
• Report Number: 8043484-2020-00180
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152163
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66021496
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/24/2020
• Initial Date FDA Received: 03/20/2020
• Supplement Dates Manufacturer Received: 01/21/2021
• Supplement Dates FDA Received: 01/25/2021
• 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: Reuse
• Patient Sequence Number: 1