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Catalog Number UNKN05003200 |
Device Problem
Leak/Splash (1354)
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Patient Problems
Unspecified Infection (1930); Skin Erosion (2075); Fluid Discharge (2686)
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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, one hcp reported that, when using exu-dry dressing to treat patients with skin graft on (b)(6) 2020, the dressing of one patient leaked due to erosion of the wound site (contaminant sludge, excretions) or because of bathing.The hcp replaced the dressing with a new one.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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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 was performed and showed other related failures.The ifu has been reviewed and contains comprehensive instructions on the safe operation and use of the device.The associated risk files contain the reported failure/harm or event.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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