MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN LIFE M 12.9X12.9 CTN10; DRESSING,WOUND,OCCLUSIVE

Model Number	66801068
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	11/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the silicon adhesion is coming off onto the plastic backing.The product has not been submitted to a customer or used on a patient.
Additional Manufacturer Narrative
H3, h6.We have now concluded our investigation for the complaint received.The device used in treatment has not been returned for evaluation.The photo provided confirms a relationship between the device and the reported event.Silicone remained on the carrier paper reducing adhesion.Potential factors that can contribute to the reported event include the wound contact layer raw material quality issue.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 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.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.
Additional Manufacturer Narrative
H10: it was identified that this event should be re-evaluated for mdr reporting.It is stated that the silicon adhesion of an allevyn life l 15.4x15.4 ctn10 is coming off onto the plastic backing, the product was not submitted to a customer or used on a patient.Therefore, if the device malfunction were to recur, it would not be likely to cause or contribute to a death or serious injury.H3, h6: the device was returned and evaluated, establishing a relationship between the device and the event reported.A visual inspection confirmed silicone offset to the carrier.The functional evaluation confirmed that the dressing had reduced adherence due to lack of silicone.The root cause is identified as a component failure, the wound contact layer within dressings can be affected by storage temperature fluctuations as detailed in the ifu.The users of the reported product are advised to consult the ifu, to prevent future occurrences of the event, which provides details of the conditions in which the device should be stored.A review of the associated batch manufacturing records did not identify any issue at the point of manufacture which may have caused or contributed to the issue highlighted by the complainant.In addition it can be confirmed that all finished product specification testing was satisfied at the point of release.The manufacturing process was reviewed and observed no manufacturing deficiencies.Silicone adhesive can be affected by storage temperature fluctuations.A complaint history review revealed a small number of similar events with no manufacturing problems observed.A risk management review concluded that the alleged failure mode and any associated harm has been anticipated within the risk file, with no updates required.Corrective action has identified that no process concerns have been observed, the action is in place relating to the silicone adhesion to the carrier paper.This investigation is now complete with no further action deemed necessary at this stage.Smith and nephew will continue to monitor for any adverse trends relating to this product range.Additional information: d4 (expiration date), d8/d9, h4 corrected data: g2.

• Brand Name: ALLEVYN LIFE M 12.9X12.9 CTN10
• Common Device Name: DRESSING,WOUND,OCCLUSIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 10987542
• Report Number: 8043484-2020-04159
• Device Sequence Number: 14249717
• Product Code: NAD
• UDI-Device Identifier: 05000223481421
• UDI-Public: 05000223481421
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/01/2023

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: 06/01/2023
• Device Model Number: 66801068
• Device Catalogue Number: 66801306
• Device Lot Number: 202024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 11/13/2020
• Supplement Date Received by Manufacturer: 01/06/2021; 09/01/2023
• Initial Report FDA Received Date: 12/10/2020
• Supplement Report FDA Received Date: 01/08/2021; 09/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown