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Catalog Number UNKNOWN |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Skin Disorders (4543)
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Event Date 08/20/2021 |
Event Type
Injury
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Manufacturer Narrative
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Reference number: (b)(4).
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Event Description
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It was reported that when using replicare ultra dressing to treat venous leg ulcers, 1 patient reported that the wound was very macerated.It is unknown if/how the adverse 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, we do not have the opportunity to identify individual hcps and revisit negative feedback to retrieve further information.
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Manufacturer Narrative
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The device, used in treatment, was not returned for evaluation.All provided information has been reviewed and we have not been able to establish a relationship between the product and reported event, or determine a root cause.Probable root cause of the reported maceration may be improper preparation of wound area or failure to change dressing as often as is necessary.No lot/serial number has been provided therefore a review of device history is not possible.A complaint history review found further instances of the reported events.The instructions for use has been reviewed and contains comprehensive instructions on the safe operation and use of the device.The associated risk files contain details relating to harm.However, the clinical review has not established a causal link.This investigation is now complete with no further action deemed necessary.Smith + nephew will continue to monitor for any adverse trends relating to this product range.
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Search Alerts/Recalls
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