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Model Number 66800959 |
Device Problem
Loss of or Failure to Bond (1068)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/04/2021 |
Event Type
malfunction
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Event Description
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It was reported that during treatment, the allevyn gb multisite silicone strongly remained on the pack when removing it for application.Also, once the dressing was being removed from the patient after it use, the silicone remained on the healthy skin or on the patient's wound.This has happened in multiple occasions, and the use of the dressing is being replaced for a competitor's dressing: mepilex from molnlycke.No patient injury or other complications were reported.
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Manufacturer Narrative
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H3, h6: the device, used in treatment, is not available for evaluation.All provided information has been reviewed and we have not been able to establish a relationship between the device and the reported event or determine a root cause.Factors that can contribute to the reported event include raw material quality issue.A review of the associated batch manufacturing records confirmed that the device met manufacturing specifications at the point of release.A complaint history review found further instances of the reported event.The instructions for use provide comprehensive instructions of the operation, use and limitations of the device.The associated risk files contain the reported failure or event.This investigation is now complete with no further action deemed necessary.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.
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Manufacturer Narrative
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The device, intended to be used in treatment, was returned for evaluation, establishing a relationship between the device and the reported event.A visual inspection found silicone offset onto the plastic handle when the plastic handles were peeled off dressing.The functional evaluation confirmed that the dressings were less adhesive.Root cause has been determined as a component failure, the wound contact layer within these dressings can be affected by storage temperature fluctuations as detailed in the ifu.The manufacturing records show no evidence that the product did not meet specification at the time of manufacture.Since no patient injuries were reported, no further clinical/medical assessment is warranted.The associated risk files contain details relating to harm.However, as no harm has been alleged then additional review is not required.The instructions for use provide comprehensive instructions of the operation, use and limitations of the device.A complaint history review has found other related events, with corrective action implemented related to the reported event.Smith + nephew will continue to monitor for adverse trends.
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Search Alerts/Recalls
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