MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN GENTLE BORDER 10X30CM; DRESSING,WOUND,OCCLUSIVE

Catalog Number 66800265

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 07/12/2019

Event Type  Injury  

Event Description

It was reported that the silicone adhesive was removed from the dressing when they removed the protection paper.A large area was shown with no silicone adhesive.The patient suffered a maceration as a result of leaking.

Manufacturer Narrative

We have now concluded our investigation for the complaint received.A review of the associated batch manufacturing records did not identify any issue at the point of manufacture which may have caused or contributed to the issue highlighted by the complainant.In addition it can be confirmed that all finished product specification testing was satisfied at the point of release.Due to the nature of the reported complaint, our clinical team were asked to perform a medical investigation.The team concluded: ¿the information provided is insufficient to determine whether the patient¿s symptoms, signs or outcome are due to a pre-existing or concurrent medical or surgical condition or procedure, or to an adverse reaction to or experience with the device, one or more of its components, or its intended therapeutic action.A thorough medical assessment cannot be rendered at this time.¿ a risk management review was carried out.Based on the information provided, there are no further actions on this as maceration is captured in smith and nephew risk files for this product.A complaints history review was carried out using the lot and part numbers provided, there have been similar complaints reported with this issue in the past four years.It was reported that silicone adhesive was removed from the dressing when the protection paper was removed.Based on the information reported, the dressing was applied to the patient with a large area of silicone missing and the patient later suffered a maceration.The returned samples were evaluated and this issue was confirmed.The wound contact surface of allevyn gentle border is coated with a gentle silicone adhesive layer that ensures non-traumatic removal at dressing changes.The silicone adhesive will feel sticky when compared to an acrylic adhesive and is specially designed to be very soft and gentle, but can soften further, particularly at higher temperatures.This is an inherent characteristic of all of the silicone adhesives and gives them their soft / gentle properties.It is therefore possible if the product has been stored at a high temperature, this could have contributed to the reported issue.It was reported that the dressing involved in this event leaked.On occasion this can be caused if the dressing is not changed frequently enough ¿ dependent on the characteristics of the wound.As stated in the instructions for use: ¿during the early stages of treatment inspect the dressing frequently.Dressings can be left in place for up to 7 days, except the sacral area where dressings can be left in place for up to 5 days.Dressings should be changed depending on the condition of the wound and surrounding skin, or until exudate is visible as strike through and approaches to within 0.5cm/ 3/16in.Of the edge of the dressing pad, whichever is sooner.¿ unfortunately we have been unable to determine a root cause on this occasion.It cannot be confirmed whether the reported maceration was caused by leaking due to adhesive offsetting or alternative factors.

• Brand Name: ALLEVYN GENTLE BORDER 10X30CM
• Type of Device: DRESSING,WOUND,OCCLUSIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull ; UK
• MDR Report Key: 8839861
• MDR Text Key: 152599677
• Report Number: 8043484-2019-00512
• 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: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 66800265
• Device Lot Number: 2018844
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2019
• Date Manufacturer Received: 01/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1