MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN LIFE XL 21X21 CTN10; DRESSING, WOUND, OCCLUSIVE

Model Number	66801070
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that two dressings from two different boxes were tested by s+n rep prior to sending to a customer for evaluation to ensure product was safe for patient use.This event did not involve a patient or hcp.Both dressings were placed on the l anterior thigh, one dressing at a time was tested.No silicone residue left on the backings upon application for both dressings.Dressing #1 - the outer edge lifted with activity but re-adhered well and stayed in place.A large amount of silicone residue left behind on the skin upon removal for dressing #1 (1 large patch measuring 7.5 x 9 cm + 5-6 small beads/patches).Borders curled on themselves upon removal and were difficult to peel apart for dressing #1.Dressing #1 pulled the skin moderately upon removal with mild to moderate amount of pain/discomfort.Dressing #2 - inner edge lifted with activity.Border folded upon itself and peeled apart, however did not re-adhere to the skin.A very small amount of silicone residue left behind on the skin upon removal for dressing #2 (1 small patch + 3-4 small beads).Borders were easier to peel apart than dressing #1.Dressing #2 pulled the skin upon removal quite a bit more than dressing #1 with moderate to high amount of pain/discomfort.
Additional Manufacturer Narrative
H3, h6: we have now concluded our investigation for the complaint received.The manufacturing records show no evidence that the product did not meet the specification at the time of manufacture, the reported file is held by the quality release team.The device intended to be used in treatment has not been returned for evaluation.Photos were provided for review and there was a relationship between the reported event and the device, however a root cause is undetermined on this occasion.Potential factors include raw material issues or storage environment issues.The complaint history file contains further instances of the reported event, currently being monitored, with actions being taken to reduce further instances.However, this investigation is now complete with no further action deemed necessary at this stage.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 LIFE XL 21X21 CTN10
• 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: 11108503
• Report Number: 8043484-2021-00002
• Device Sequence Number: 3596493
• Product Code: NAD
• UDI-Device Identifier: 05000223478070
• UDI-Public: 05000223478070
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2021

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: 66801070
• Device Catalogue Number: 66801070
• Device Lot Number: 202029
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/10/2020
• Supplement Date Received by Manufacturer: 12/10/2020
• Initial Report FDA Received Date: 01/04/2021
• Supplement Report FDA Received Date: 02/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1