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Model Number 810081L |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120)
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Event Date 01/01/2023 |
Event Type
Injury
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Event Description
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It was reported that a patient underwent an unspecified procedure on 07-dec-2021 and mesh was implanted.The patient reported experiencing searing pain in the left thigh on waking after mesh insertion.Within the days, weeks and months following the surgery, the patient also experienced acute retention of urine on d3 post-op, recurrent urinary tract infections, difficult urination and sciatica / cruralgia pain on the left side.No further information is available as the reporter contact details were not 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: (b)(4)¿ device not returned.
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Search Alerts/Recalls
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