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Catalog Number UNKN05004800 |
Device Problems
Moisture or Humidity Problem (2986); 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 05/28/2021 |
Event Type
Injury
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Event Description
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It was reported that, when using opsite post-op waterproof to treat patients with abrasions / cuts / lacerations, cuts and abrasions, it was reported that, due to moisture collection somewhat macerated the wound edges.It is unknown if/how event was resolved.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.All provided information has been reviewed and we have not been able to establish a relationship between the device and the reported event or determine a root cause.Probable causes may include, application, removal, time left on patient, trauma, materials used within the dressing.No lot/serial number has been provided therefore a review of manufacturing records is not possible.A complaint history review found other related events.The instructions for use provide comprehensive instructions of the operation, use and limitations 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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Event Description
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It was reported that, when using opsite post-op waterproof to treat patients with abrasions / cuts / lacerations, cuts and abrasions, it was reported that, due to moisture collection, the skin was somewhat macerated at the wound edges.It is unknown if/how event was resolved.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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Search Alerts/Recalls
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