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Catalog Number 66801196 |
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 01/31/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Internal complaint reference: (b)(4).
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Event Description
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It was reported that, when the carrier was removed, much of the silicone adhesive removed with the carrier and did not remain on the film, so it could not be used.No delay was reported.The issue was found before the dressing was applied to skin.Patient was not harmed.
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Manufacturer Narrative
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Internal complaint reference: (b)(4).
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Event Description
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It was reported that, when the carrier was removed, much of the silicone adhesive removed with the carrier and did not remain on the film, so it could not be used.No delay was reported.The issue was found before the dressing was applied to skin.Patient was not harmed.
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Manufacturer Narrative
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H3, h6: the device was returned for evaluation, confirming the reported event.Visual inspection noted no obvious defects, functional evaluation confirmed silicone remained on the carrier reducing adherence.The root cause has been deemed a component failure, the instructions for use, detail the wound contact layer within these dressing can be affected by storage temperature fluctuations.A documentation investigation has been conducted, confirming that no manufacturing problems have been observed.Complaint history shows previous events of this nature, with corrective actions assigned.The complained product was released after the actions being initiated.The instructions for use and risk files, mitigate the reported issue with no updates required.Smith and nephew can confirm the device was released according to specifications and continue to monitor for adverse trends relating to this product range.This investigation is now complete with no additional corrective actions deemed necessary.
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Search Alerts/Recalls
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