MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN GENT BORDER 15X15CM 10; DRESSING,WOUND,OCCLUSIVE

Catalog Number 66800975

Device Problem Insufficient Information (3190)

Patient Problem Skin Irritation (2076)

Event Date 01/29/2020

Event Type  Injury  

Event Description

It was reported that during treatment the dressing needed to be changed, there was a large amount of wound exudate left in the wound and on the surrounding skin, also the patient presented maceration and irritating skin.

Manufacturer Narrative

The device, used in treatment, has not been returned for evaluation.No control sample or photos have been provided.This assessment was unable to establish a relationship between the reported event.A review of the device history was not possible as details of the batch/lot number has not been provided on this occasion, however there were no indications to suggest the device did not meet product specifications.Complaint history reviewed found only this complaint relating to absorbency, all complaints are monitored to determine if additional actions are required.Our clinical team determined: ¿without the requested clinical information, a thorough medical investigation cannot be rendered.Per e-mail communication the patient has healed.Should any additional clinical information be provided this complaint will be re-evaluated.¿ the ifu has been reviewed which contains adequate warnings, cautions including, dressings can be left in place for up to 7 days depending on the condition of the wound and the surrounding skin or until exudate is visible and approaches to within 1.5cm of the edge of the dressing pad, whichever is sooner.It is advisable to select an appropriate dressing according to the individual patients needs.We have been unable to determine a root cause on this occasion.No further actions by smith and nephew are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.

• Brand Name: ALLEVYN GENT BORDER 15X15CM 10
• Type of Device: DRESSING,WOUND,OCCLUSIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• MDR Report Key: 9875915
• MDR Text Key: 185725402
• Report Number: 8043484-2020-00202
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 66800975
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention