It was reported that after orthopedic surgery in the trochanter, while the patient was using the pico dressing, it did not absorb the exudate which was accumulated in the surrounding skin, causing skin irritation and dermatitis.The dressing was applied for 5 days, and it had no visible sign of exudate in the absorbent layer.The customer replaced the pico and maintained the treatment.The skin was cleaned and protected with secura.No medical intervention needed, no patient harm.
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We have now concluded our investigation for the complaint received.A review of the batch manufacturing records could not be performed as no lot number was provided, however, there are no indications to suggest that the device did not meet specifications upon release into distribution.A complaint history review was carried out using the part number provided, there have been further complaints reported with this issue.The device was used for treatment.As the device was not returned a product evaluation could not be carried out.An image provided confirmed the skin irritation but not the reported adhesive or absorbency issues.A clinical assessment was carried out.It was concluded: ¿the photo provided confirm the reported irritation, however, the information provided is insufficient to determine whether the patient¿s symptoms, signs or outcome are due to a pre-existing or concurrent medical or surgical condition or procedure, or to an adverse reaction to or experience with the smith and nephew device.Per subsequent e-mail, this event was treated by cleansing the skin and protected with secura.No medical intervention was required.Since there was no harm, alleged to this patient, no further clinical/medical assessment is warranted at this time.Should any additional medical information be provided this complaint will be re-assessed.¿ the wound contact surface of pico is coated with a gentle silicone adhesive layer that ensures non-traumatic removal at dressing changes.The silicone adhesive will feel sticky when compared to an acrylic adhesive and is specially designed to be very soft and gentle, but can soften further, particularly at higher temperatures.This is an inherent characteristic of all of the silicone adhesives and gives them their soft / gentle properties.It is therefore possible if the product has been stored at a high temperature, this could have contributed to the reported issue.It was reported that there were absorbency issues in which exudate was accumulated on the surrounding skin.A possible cause for this is if the device was used on a highly exuding wound.The pico 7 kit is designed for low to moderately exuding wounds.It was reported that the dressing was in place for 5 days.Although the dressing may be left in place for up to 7 days, dressing changes are typically required every 3-4 days.We have not been able to confirm a relationship between the event and the device or identify a definitive root cause.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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