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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); Ambulation Difficulties (2544)
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Event Date 11/01/2021 |
Event Type
Injury
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Event Description
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It was reported that a patient underwent a sling procedure on 11/17/2021 and mesh was implanted.The patient reported experiencing intense pain in adductors, buttocks, hips, thighs, tingling legs and feet along with significant pelvic pain.The patient has also experienced loss of physical abilities and inability to move for periods.The patient reported that the urologist did not explain the course of the intervention nor the risks of complications.No further information is available.
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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 manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.
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Search Alerts/Recalls
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