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Catalog Number UNKN05003200 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Localized Skin Lesion (4542); Skin Disorders (4543)
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Event Date 05/24/2021 |
Event Type
Injury
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Event Description
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It was reported that, when using exu-dry dressing to treat patients with bio-engineered skin substitutes, one patient was not satisfied with the surrounding (peri to wound) skin health.The patient indicated that the condition of the skin deteriorated, requiring additional treatment.No further information was provided regarding the reported event.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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H3, h6: the device used in treatment was not returned for evaluation, with all information provided we have not been able to establish a relationship between the device and the reported event or determine a root cause.Probable root cause includes application technique, good wound contact is essential.Daily dressing changes are recommended.No lot/serial number has been provided; therefore, a document review is not possible.A complaint history review found further instances of the reported event.The ifu 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.Additional rmr is not required.This investigation is now complete with no further action deemed necessary.Smith and 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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