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Catalog Number 66974939 |
Device Problem
Contamination (1120)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/24/2021 |
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, during wound treatment, there was a brown foreign substance under the film of the wound-contact side of the dressing of a melolin sterile 20x10cm ctn 100.This happened before use in patient.Treatment was performed, without any delay, with a back-up device instead.Patient was not harmed as consequence of this problem.
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Manufacturer Narrative
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The device, intended for use in treatment, was returned for evaluation.The visual evaluation confirms a brown foreign substance under the film of the wound-contact side of the dressing, establishing a relationship between the device and the reported event.The root cause was identified as a manufacturing process 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.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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