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Catalog Number UNKN05004800 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Post Operative Wound Infection (2446)
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Event Date 01/01/2004 |
Event Type
Injury
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Manufacturer Narrative
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Internal complaint reference (b)(4).Wynne, r., botti, m., stedman, h., holsworth, l., harinos, m., flavell, o., & manterfield, c.(2004).Effect of three wound dressings on infection, healing comfort, and cost in patients with sternotomy wounds: a randomized trial.Chest, 125(1), 43-49.Doi: 10.1378/chest.125.1.43.
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Event Description
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On the literature article named "effect of three wound dressings on infection, healing comfort and cost in patients with sternotomy wounds: a randomized trial", the authors of the study reported that, when using an opsite dressing to treat postoperative patients with sternotomy wounds, 4 patients developed an unspecified superficial sternal wound infection (involving skin and subcutaneous tissues), within a time range of 1 to 5 postoperative days.In conjunction with this adverse event, one of the following interventions were conducted: excision of wound tissue, a positive wound culture finding or treatment with antibiotics, although it was not specified which one was conducted for each patient/adverse event within the study.
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Manufacturer Narrative
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H3, h6: the complaint was received as a result of issues being identified in a post market clinical survey.Due to this, no specific product details or batch/lot numbers have been available to the investigation.As a result of this, no device history review was possible.A complaint history review was possible as it was performed for the product family and event description, there have been further instances in the past three years.According to the survey, the devices were being used in patient treatment.The devices used for treatment have not been returned to smith and nephew for analysis.We have therefore not been able to confirm a relationship between the event and the device or identify a definitive root cause.No relevant supporting clinical information has been provided to assist with a clinical investigation.The patient's current condition is unknown and the patient impact beyond the reported events could not be determined based on the limited information provided.Therefore, based on insufficient information, a thorough clinical assessment cannot be performed at this time.Should any additional clinical information be provided this complaint will be re-evaluated.The medical review could not establish a link between the product and harm within this complaint and therefore additional rmr is not required.Users of the device are advised to consult the instructions for use, to delineate future occurrences of the reported issue.This guide provides comprehensive instructions of the operation, use and limitations of the device, including advice on application and removal of dressings.This investigation has now been closed with no corrective actions required.No further actions by smith and nephew are deemed necessary at this stage.Smith and nephew acknowledge customer concern and are grateful for all feedback on our products, as this information is extremely valuable to us, as we are continually investigating ways to develop and improve the full range of products that we provide.We will continue to monitor for any adverse trends relating to all product ranges.
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Search Alerts/Recalls
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