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Catalog Number 810081 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Incontinence (1928); Pain (1994); Urinary Retention (2119); Ambulation Difficulties (2544); Unspecified Tissue Injury (4559)
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Event Date 08/28/2023 |
Event Type
Injury
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Event Description
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It was reported that a patient underwent a sling procedure on (b)(6) 2023 and mesh was implanted.The patient reported inability to urinate so returning to the operating room to loosen the suburethral strip.Since then, the patient reported having had severe stomach pain, restless legs syndrome, a medical restriction at work because prolonged standing is very painful and a double enthesopathy of the gluteus medius for several months.This was confirmed by an translabial ultrasound.The patient has an appointment in (b)(6) for complete removal of the strip.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.
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Search Alerts/Recalls
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