MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN LIFE L 15.4X15.4 CTN10; DRESSING,WOUND,OCCLUSIVE

Model Number	66801069
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference number: case-(b)(4).
Event or Problem Description
It was reported that when opening the single product package, drops of silicone loose from the dressing were noticed in the wrapper.There was a subsequent difficulty in adhesion requiring reinforcement.Even so, the duration of the dressing at the site decreased.The dressing only lasted 1 day.Treatment was completed with a back-up with no delay.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
We have now completed our investigation into the reported complaint.The device used in treatment has not been returned for evaluation, with no additional information provided.We have not been able to establish a relationship between the device and the event reported or determine a root cause on this occasion.It was reported that the drops of silicone loosened from the dressing and the adhesion decreased.Factors that can contribute to the reported event include, raw material issues or storage environment issues.The manufacturing records show no evidence that the product did not meet specification at the time of manufacture.The complaint history file contains further instances of the reported events.An ongoing internal action is being carried out into the reported failure mode to reduce further instances of the reported event, 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 L 15.4X15.4 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: 11492295
• Report Number: 8043484-2021-00587
• Device Sequence Number: 16888885
• Product Code: NAD
• UDI-Device Identifier: 05000223478049
• UDI-Public: 05000223478049
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2021

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: 66801069
• Device Catalogue Number: 66801069
• Device Lot Number: 202022
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/23/2021
• Supplement Date Received by Manufacturer: 04/09/2021
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 04/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1