ETHICON INC. TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD; 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
Fatigue (1849); Hemorrhage/Bleeding (1888); Memory Loss/Impairment (1958); Nausea (1970); Pain (1994); Unspecified Kidney or Urinary Problem (4503)
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Event Date 01/01/2020 |
Event Type
Injury
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Event Description
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It was reported that a patient underwent a gynecological procedure in (b)(6) 2009 and mesh was implanted for stress incontinence.The patient reported experiencing unusual vaginal bleeding in (b)(6) 2020.It was during investigations into this that the patient discovered she had the mesh implant.The patient also has had ongoing nausea since (b)(6), chronic pain throughout the body, ongoing bladder issues and suffers from chronic fatigue, memory issues and brain fog.The patient believes that the mesh implant is responsible for the ongoing issues.No further information is available as the contact details have not been disclosed.
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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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Search Alerts/Recalls
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