MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. RENASYS F MEDIUM W/ SOFT PORT; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Catalog Number 66800795

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Skin Erosion (2075)

Event Date 08/20/2018

Event Type  Injury  

Event Description

It was reported that the patient developed skin reaction to the renasys film around the foam so the dressing was removed.The surrounding skin broken down after application of film dressing securing renasys foam whilst pump in situ.This patient had a prior existing skin condition, that appeared to be exacerbated by the use of the adhesive dressing, the consultant had reviewed the patient & decided that he wanted the patient to continue on the renasys appliance, the hospital tvn had assessed the patient & recommended the use of cavilon advance prior to applying the adhesive dressing, this is working effectively, no redness on the surrounding skin.

Manufacturer Narrative

As of today, device return has been requested for this complaint but has not become available.Without return of the actual device we cannot further investigate or confirm the details supplied in this complaint.A device history record review could not be carried out as a batch or serial number was not provided.Due to the nature of this complaint, the issue was referred to a clinical specialist for an opinion.The clinical specialist concluded as follows.Insufficient clinically relevant documentation was provided, therefore, a thorough medical investigation could not be performed.However, it was communicated that the patient's pre-existing skin condition contributed to the reported event and that the use of a skin protectant/barrier "is working effectively" with "no redness on the surrounding skin".No further patient impact is expected as the transient exacerbation of a pre-existing skin condition has reportedly resolved with use of revised application regimen.

• Brand Name: RENASYS F MEDIUM W/ SOFT PORT
• 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
• MDR Report Key: 7871210
• MDR Text Key: 120094763
• Report Number: 8043484-2018-00291
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K110647
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 66800795
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/21/2018
• Initial Date FDA Received: 09/12/2018
• Supplement Dates Manufacturer Received: 08/21/2018
• Supplement Dates FDA Received: 11/06/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other