MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN ADHESIVE; DRESSING,WOUND,OCCLUSIVE

Catalog Number UNKNOWN

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

Patient Problems Impaired Healing (2378); Insufficient Information (4580)

Event Date 03/28/2019

Event Type  Injury  

Manufacturer Narrative

Internal reference number: (b)(4).

Event Description

On the literature article name "multicenter randomized controlled trial comparing the effectiveness and safety of hydrocellular and hydrocolloid dressings for treatment of category ii pressure ulcers in patients at primary and long-term care institutions", it was reported that, when using a hydrocellular dressing (allevyn adhesive) to treat category 2 pressure ulcers, the ulcers of 4 patients got worse and progressed to category 3.It is unknown if / how the adverse event was treated.

Manufacturer Narrative

The complaint was received as a result of issues being identified in a literature article.Due to this, no specific product details or batch/lot numbers have been available to the investigation.As a result of this, no device history review was possible.A complaint history review was performed for the product family and event description, there have been further instances in the past three years.According to the article, the devices were being used in patient treatment.The devices used for treatment have not been returned to smith and nephew for analysis.We have therefore not been able to confirm a relationship between the event and the device or identify a definitive root cause.No relevant supporting clinical information has been provided to assist with a clinical investigation.The patient's current condition is unknown and the patient impact beyond the reported events could not be determined based on the limited information provided.Therefore, based on insufficient information, a thorough clinical assessment cannot be performed at this time.Should any additional clinical information be provided this complaint will be re-evaluated.The medical review could not establish a link between the product and harm reported within this complaint.Users of the device are advised to consult the instructions for use, to reduce future occurrences of the reported issue.This guide provides comprehensive instructions of the operation, use and limitations of the device, including advice on application and removal of dressings.This investigation has now been closed.No further actions by smith and nephew are deemed necessary at this stage.We will continue to monitor for any adverse trends relating to all product ranges.

• Brand Name: ALLEVYN ADHESIVE
• Type of Device: DRESSING,WOUND,OCCLUSIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; hessle road; hull east riding of yorkshire; HU3 2 BN; UK HU3 2BN
• MDR Report Key: 12368852
• MDR Text Key: 268209957
• Report Number: 8043484-2021-01693
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature,other,user
• Type of Report: Initial,Followup
• Report Date: 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention