MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN LIFE SACRUM (SMALL) PACK OF 10; DRESSING, WOUND, OCCLUSIVE

Model Number	66021306
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the silicon adhesion is coming off onto the plastic backing.The product has not been submitted to a customer or used on a patient.
Additional Manufacturer Narrative
H3,h6: we have now concluded our investigation into this complaint.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.The complaint history file contains further instances/ related events of the reported event.The device, intended for use in treatment, was not returned for evaluation.However a relationship between the reported event and the device was confirmed from images provided.The wound contact surface of allevyn life 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.An ongoing internal project is being carried out into this failure mode, therefore no further actions are deemed necessary into this specific complaint.Smith and nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.We will continue to monitor for any adverse trends relating to this product range.

• Brand Name: ALLEVYN LIFE SACRUM (SMALL) PACK OF 10
• Common Device Name: DRESSING, WOUND, OCCLUSIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 10937387
• Report Number: 8043484-2020-04020
• Device Sequence Number: 14592496
• Product Code: NAD
• UDI-Device Identifier: 05000223481421
• UDI-Public: 05000223481421
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 66021306
• Device Catalogue Number: 66801306
• Device Lot Number: 202022
• Initial Date Received by Manufacturer: 11/06/2020
• Supplement Date Received by Manufacturer: 01/05/2021
• Initial Report FDA Received Date: 12/03/2020
• Supplement Report FDA Received Date: 01/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1