ETHICON INC. TENSION FREE VAGINAL TAPE - EXACT UNKNOWN PRODUCT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
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Device Problem
Migration (4003)
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Patient Problems
Erosion (1750); Hemorrhage/Bleeding (1888); Neuropathy (1983); Pain (1994); Cramp(s) /Muscle Spasm(s) (4521)
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Event Date 01/01/2020 |
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) 2016 and mesh was implanted for incontinence.The patient experienced erosion through the left side of the vaginal wall, bleeding during intercourse, painful intercourse, pain lasting several days, neuropathy in both feet, back pain, sore hips, muscle spasms in feet, compromised immune system and always feeling unwell and rundown.A procedure was done under anesthetic with a camera to check for damage and the erosion was found.Complete mesh removal was performed on (b)(6) 2023.No further information is available as reporter details have not been disclosed (confidential).
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Search Alerts/Recalls
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