Udi: product information not available.Seven (7) cases of wound infection reported in literature article.No product failure indicted.In case of infection as in this instance, infection requiring revision of the surgical site is assessed as a serious injury resulting in the need for medical or surgical intervention in order to preclude permanent injury, damage, or death.No patient specific identifiers provided.Three requests for additional information sent to author and no response returned.One medwatch will be sent for 7 cases.This complaint was generated from literature review for health authority reporting purposes.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the pms identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Sample not available.
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