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Catalog Number UNKN05000505 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Impaired Healing (2378); Tissue Breakdown (2681); Localized Skin Lesion (4542)
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Event Date 05/25/2021 |
Event Type
Injury
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Event Description
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It was reported that, when using allevyn ag non-adhesive to treat a patient with diabetic ulcers, slight maceration around wound wedges was presented.It is unknown if/how the event was treated.This incident was noticed in a retrospective post-market clinical follow up activity (pmcf) where anonymized data summarizing outcomes were gathered; therefore, additional information is not known, and it is not possible to collect it.
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Event Description
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It was reported that, when using allevyn ag non-adhesive to treat a patient with diabetic ulcers, slight maceration around wound edges was present.It is unknown if/how the event was treated.This incident was noticed in a retrospective post-market clinical follow up activity (pmcf) where anonymized data summarizing outcomes were gathered; therefore, additional information is not known, and it is not possible to collect it.
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Manufacturer Narrative
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H10: the complaint was received as a result of issues being identified in a post market clinical survey.Due to this, no specific product details or batch/lot numbers have been available to the investigation.As a result of this, no device history review was possible.A complaint history review was performed for the product family and event description, there have been further instances in the past three years.According to the survey, the devices were being used in patient treatment.The devices used for treatment have not been returned to smith and nephew for analysis.We have therefore not been able to confirm a relationship between the event and the device or identify a definitive root cause.As no further information is available, it is not possible to establish a link between the product and harm within this complaint.No relevant supporting clinical information has been provided to assist with a clinical investigation.The patient's current condition is unknown and the patient impact beyond the reported events could not be determined based on the limited information provided.Therefore, based on insufficient information, a thorough clinical assessment cannot be performed at this time.Should any additional clinical information be provided this complaint will be re-evaluated.Users of the device are advised to consult the instructions for use, to reduce future occurrences of the reported issue.This guide provides comprehensive instructions of the operation, use and limitations of the device, including advice on application and removal of dressings.This investigation has now been closed.No further actions by smith and nephew are deemed necessary at this stage.We will continue to monitor for any adverse trends relating to all product ranges.B5: updated description.H6: updated codes.
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Search Alerts/Recalls
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