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Model Number 810081L |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problems
Abdominal Pain (1685); Micturition Urgency (1871); Hemorrhage/Bleeding (1888); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Urinary Frequency (2275); Discomfort (2330); Prolapse (2475); Constipation (3274)
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Event Type
Injury
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Event Description
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It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6)2010 and mesh was implanted.It was reported that the patient experienced vaginal bleeding, constipation, stress incontinence, rectocele, nocturia, incomplete emptying, urgency, dyspareunia, urgency incontinence, back pain, urinary tract infections, thrush, coccyx pain, buttock pain, hip pain, groin pain, vaginal discharge, urinary frequency, dysuria and abdominal pain.No additional information was provided.
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Manufacturer Narrative
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Date sent to fda: 6/8/2023.To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, 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.
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Manufacturer Narrative
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Date sent to the fda: 06/14/2023.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.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, or its employees that the report constitutes an admission that the product, ethicon, 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.
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Search Alerts/Recalls
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