ETHICON INC. TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Sepsis (2067); Urinary Tract Infection (2120); Unspecified Mental, Emotional or Behavioural Problem (4430)
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Event Date 05/30/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.To date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.H6 component code: g07002 ¿ device not returned.
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Event Description
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It was reported that a patient underwent a sling procedure on (b)(6) 2019 and mesh was implanted.The patient went into the hospital believing she was having a hysterectomy.The patient became septic and was admitted to the hospital for iv antibiotics.The patient was in the hospital with a catheter, in the care of her daughter due to delirium.The patient then had surgery to dissect the sling on (b)(6) 2020.A brain scan was performed to diagnose vascular dementia.Since then, the patient saw a doctor who did a d&c on an unknown date.The patient experienced post operative delirium, onset of dementia, now has moderate alzheimer¿s disease and recurring urinary tract infections.The patient is in an aged care facility.No further information is available as reporter details have not been disclosed (confidential).
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