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	03/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient received some allevyn dressings, the first one was not used due to decreased adhesive a second one was used as only a small nickel size area was missing.The rest were not open but the customer assumes since first 2 were defective, the rest may be as well.Patient also had to use some of his personal back stock he purchased independently since they are not sticking well.
Additional Manufacturer Narrative
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 small number of similar instances reported in the past three years.There is no indication tht this is outside of acceptable rates of occurrence.Event occurred during patient treatment.The device used in treatment was not returned for evaluation, therefore no functional evaluation could not be carried out, therefore we have not been able to establish a relationship between the reported complaint and the device.It has not been possible to establish the root cause of the issue.It was reported that the dressing did not adhere to the patient¿s skin satisfactorily due to lack of adhesion.A probable root cause of low adhesion may be caused by insufficient adhesion levels of the raw material used to make the film of this dressing.There are various controls in place during the manufacturing process of both the raw material and the dressing to identify when the adhesion is not in acceptable range, as per the product specification.There are also regular tests carried out to monitor the finished product.As with all adhesive products, the skin site must be thoroughly cleaned and dried prior to application.If there is any moisture on the skin surrounding the catheter, the adhesive performance of this dressing may be compromised.If the dressing becomes wet whilst applied, it may have to be removed and a new dressing applied.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 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: 11553617
• Report Number: 8043484-2021-00668
• Device Sequence Number: 4075702
• Product Code: NAD
• UDI-Device Identifier: 05000223478049
• UDI-Public: 05000223478049
• 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,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2021

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/01/2021
• Supplement Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 03/23/2021
• Supplement Report FDA Received Date: 09/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1