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Catalog Number 66800274 |
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 gentle border 8x8cm 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, has not been returned 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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Search Alerts/Recalls
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