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Catalog Number UNKN05003200 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Unspecified Infection (1930)
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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, although there was no presence of purulent drainage from the wound, one patient was dissatisfied with our product due to the development of an infection, reportedly from the dressing.No further information was provided.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.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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