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Catalog Number 810041 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Urinary Tract Infection (2120)
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Event Date 01/01/2023 |
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.A review of the batch manufacturing records was conducted, and no related non-conformances were identified.
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Event Description
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It was reported that a patient underwent a sling procedure on (b)(6) 2004 and mesh was implanted.The patient reported the following: one month after the implantation of mesh strips, first urinary infection even though patient had never had one.At first, urinary infections fairly spaced then for around ten years minimum one or two per month and for three years one per week with intense vaginal pain.No more sexual intercourse possible because of the pain since at least three years.Patient on antibiotics all the time which leads to other problems.During this period the patient always been followed and consulted numerous urologists, gynecologists and an infectious disease specialist so that in the end the last urologist confirms to the patient that these recurrent infections come from the strip.The patient's current condition includes continuous painful urinary tract infections, severe vaginal pain, impossibility of vaginal penetration and loss of libido.No further information is available as the reporter contact details were not disclosed.
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Search Alerts/Recalls
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