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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 12/09/2021 |
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 treatment, utilizing opsite flexifix gentle 5cmx5m, was detected that the most of the silicone glue sticks to the protective plastic and not to the film.This prevents the patch from sticking to the patient.It was change in treatment technique.Patient was not harmed.
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Manufacturer Narrative
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The device was not returned for evaluation.Without a physical sample, we cannot confirm the reported event.The wound contact layer within these dressing can be affected by storage temperature fluctuations as detailed in the instructions for use.A documentation investigation has been conducted, confirming that the product met manufacturing specifications upon release for distribution.Complaint history shows previous events of this nature, with corrective actions assigned.The complained product was released prior to 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 at this time.D4: corrected expiration date.
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Event Description
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It was reported that, during treatment, utilizing opsite flexifix gentle 5cmx5m, most of the silicone glue sticks to the protective plastic and not to the film.This prevents the patch from sticking to the patient.Treatment was continued using an alternate method.No patient harm reported.
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Search Alerts/Recalls
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