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Catalog Number UNKN05005100 |
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 a primapore dressing to treat postoperative patients with sternotomy wounds, 5 patients developed an unspecified deep wound infection (involving muscle, bone and/or mediastinum), 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 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 reported event or determine a root cause.Probable root cause may include, wound criteria and after care.Medical review concluded, the root cause and/or patient outcome beyond that which was documented in the article cannot be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.The associated risk files contain details relating to harm.However, the clinical review has not established a causal link.Additional review is not required.The instructions for use provide comprehensive instructions of the operation, use and limitations of the device.No lot/serial number has been provided; therefore, a review of the device history is not possible, complaint history review found further instances of the reported event.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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Search Alerts/Recalls
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