MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN GENTLE BORDER 7.5X7.5CM INT; DRESSING,WOUND,OCCLUSIVE

Catalog Number 66800269

Device Problem Material Disintegration (1177)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/29/2020

Event Type  malfunction  

Event Description

It was reported that on removal of the sacral dressing, some particles of silicone remained on the patient's skin surrounding the wound.On removal of the 15x15cm dressing, again, some particles of silicone remained on the patient's skin surrounding the wound.The wounds were both cavities and there was risk the silicone could end up in the wounds.These occurred on different patients, on different wards and different sites within the trust.On opening a new dressing 7.5x7.5cm, parts of the silicone remained on the film cover.It is unknown how many patients are involved.No patient harm reported.

Manufacturer Narrative

The device, used in treatment, has not been received for evaluation.No samples or further details were supplied, therefore we are unable to establish a relationship between the device and the event reported or determine a root cause on this occasion.No batch/lot details have been provided, due to this we are unable to conduct a review of the device history.However, at this time we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A complaint history for the reported event has been reviewed revealing further instances in the past three years.The wound contact surface 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.No further actions are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.Smith + nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.

• Brand Name: ALLEVYN GENTLE BORDER 7.5X7.5CM INT
• 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: 10376740
• MDR Text Key: 201990094
• Report Number: 8043484-2020-02320
• 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: 10/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66800269
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1