Our investigation into this complaint has now concluded.As of today, no product return for this complaint has become available preventing a more thorough investigation.Without return of the actual device we cannot further investigate or confirm the details supplied in this complaint and try to determine a root cause.If the device is returned in the future then this complaint may be reopened.A dhr has not been possible as reasonable effort to obtain a lot number have not been successful.A complaints history review has been run for unknown opsite flexigrid however no further complaints of this nature have been reported.Due to the nature of this complaint it has been forwarded to our clinical experts who have concluded the following it has been communicated via email that no relevant supporting clinical information will be provided, and there is no report of the patient's current condition.However, per the patient information leaflet for ametop gel, possible side effects include: frequently; redness of the skin.Less frequently; itching and swelling of the skin.Rarely: itching and swelling of the skin.Therefore, based on insufficient information, a thorough clinical assessment cannot be performed at this time.On this occasion we have not been able to identify a definitive root cause for the device.Smith and nephew are continually investigating ways to develop and improve our products.We will continue to monitor for any adverse trends relating to this product range.
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