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Model Number 66800264 |
Device Problem
Nonstandard Device (1420)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/17/2021 |
Event Type
Injury
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Event Description
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It was reported that, while checking the allevyn devices and upon removing the backing on this dressing almost all of the adhesive on the pad comes off on the backing.No case involved; therefore, no patient involvement.
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Manufacturer Narrative
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H3, h6: we have now completed our investigation into the reported complaint.The device intended to be used in treatment has not been returned, however the supplied photos have been reviewed, establishing a relationship with the reported event.It was reported that the adhesive on the pad comes off on the backing.A wound contact layer raw material quality issue has been identified as the root cause.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.An ongoing internal action is being carried out into the reported failure mode to reduce further instances of the reported event, therefore no further actions are deemed necessary into this specific complaint.Smith and nephew will continue to monitor for any adverse trends relating to this product range.
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Search Alerts/Recalls
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