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Catalog Number 66000041 |
Device Problem
Failure to Unfold or Unwrap (1669)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/30/2021 |
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 when the separation of the opsite flexifix 10cmx10m ctn 1 was initiated, to send the patient to the resident, the product was found to have the back of the dressing adhered to the roller, when trying to remove it, the product began to get damaged.No delay to the treatment reported or patient harm.
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Manufacturer Narrative
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Section: h3, h6: the batch record was reviewed and it could be confirmed that the products had progressed through a satisfactory release process which involved testing the product against the requirements of the finished product specification.There was also no issue identified during the manufacturing process that could have caused or contributed to the complaint problem.A complaint history review found a small number of similar instances of the reported event.There is nothing to indicate that this is outside of acceptable rates of occurrence.The device was used for treatment and was not returned for analysis.We have not been able to confirm a relationship between the event and the device or identify a definitive root cause.It was reported that the dressing adhered to the backing when it was attempted to peel it.Probable root cause is an environmental issue such as temperature.A change in temperature can alter the adhesive nature of the dressing making it adhere to the backing paper.The device must be stored in accordance with the conditions detailed in the ifu.The users of the reported product are therefore advised to consult the ifu, to delineate future occurrences of the reported issue.This guide provides comprehensive instructions of the operation, use and limitations of the device, including the correct conditions in which the device should be stored no further actions by smith and nephew are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.Smith and nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.
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Search Alerts/Recalls
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