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

Model Number	66801307
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an allevyn life sacrum dressing was applied for pressure injury prevention.When the dressing was pulled back to assess the skin, a large amount of silicone residue was left behind on the patient's skin.The silicone adhesive was too tacky as it pulled some of the patient's skin off, which was visible on the dressing.Did not cause a break in the skin.Treated with zinc oxide barrier cream which resolved the issue.No infection or other adverse events reported.
Additional Manufacturer Narrative
H6: we have now concluded our investigation into the reported complaint.As no lot number information was provided a review of the device history record could not be carried out.A complaint history review, was performed for the product and event description, there have been a very small number of similar instances reported in the past three years.Event occurred during patient treatment.The device intended for use in treatment was not returned for evaluation, therefore no functional evaluation could not be carried out.It has not been possible to establish the root cause of the issue.We have not been able to establish a relationship between the reported complaint and the device.The investigation has been closed.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.Smith and nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.

• Brand Name: ALLEVYN LIFE SACRUM (LARGE) 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: 11580367
• Report Number: 8043484-2021-00694
• Device Sequence Number: 4882393
• Product Code: NAD
• UDI-Device Identifier: 05000223481452
• UDI-Public: 05000223481452
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2021

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: Health Professional
• Device Model Number: 66801307
• Device Catalogue Number: 66801307
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/03/2021
• Supplement Date Received by Manufacturer: 07/16/2021
• Initial Report FDA Received Date: 03/28/2021
• Supplement Report FDA Received Date: 07/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1