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Catalog Number 66391068 |
Device Problem
Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/28/2021 |
Event Type
malfunction
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Event Description
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It was reported that, when the release film was removed from the hydrosite life m 12.9x12.9 ctn10, about a half silicone adhesive was removed and did not remain on the dressing, so it could not be used.A smith and nephew back up device was available.
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Manufacturer Narrative
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The devices, used in treatment, the carrier has been received for evaluation, establishing a relationship between the device and the reported event.A visual inspection confirmed silicone remained on the carrier, with the root cause, identified as a raw material 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 events.This investigation is now complete with no further action deemed necessary at this stage.Smith + nephew are taking further actions relating to the failure reported and continue to monitor for adverse trends.
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Search Alerts/Recalls
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