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	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during treatment the silicone contact layer seems to be sticking to the backing of the dressing when taken off to apply.Then the product is not staying in place as it should, and as it has done in the past.It is falling off between nurse visits.Patient stated that he has been able to ¿slide finger into dressing border where the dressing isn't staying adhered to skin¿ which is unusual for the dressing as previously no issues.No patient harm reported.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 concluded our investigation for the complaint received.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 reported event or determine a root cause on this occasion.Potential factors include raw material issues or storage environment issues.The manufacturing records show no evidence that the product did not meet the specification at the time of manufacture.The complaint history review found further instances of the reported event.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 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: 11243369
• Report Number: 8043484-2021-00191
• Device Sequence Number: 17033216
• Product Code: NAD
• UDI-Device Identifier: 05000223478049
• UDI-Public: 05000223478049
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2021

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 Expiration Date: 09/01/2021
• Device Model Number: 66801069
• Device Catalogue Number: 66801069
• Device Lot Number: 201839
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/06/2021
• Supplement Date Received by Manufacturer: 02/17/2021
• Initial Report FDA Received Date: 01/28/2021
• Supplement Report FDA Received Date: 03/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR