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Model Number 810081L |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problems
Bacterial Infection (1735); Bone Fracture(s) (1870); Micturition Urgency (1871); Hemorrhage/Bleeding (1888); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Urinary Retention (2119); Abnormal Vaginal Discharge (2123); Urinary Frequency (2275); Discomfort (2330); Prolapse (2475); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Injury
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Manufacturer Narrative
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Date sent to fda: 5/23/2023.H6: appropriate term / code not available (e2402) utilized to capture vaginal bulge and vaginal odor.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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Event Description
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It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2011 and two mesh products were implanted.It was reported that the patient underwent a gynecological surgical procedure on (b)(6) 2012 and mesh was implanted.It was reported that the patient experienced hip pain, coccyx fracture, back pain, stress incontinence, urinary retention, dyspareunia, vaginal bulge, rectocele, lower abdominal discomfort, vaginal discharge, vaginal odor, urgency, frequency, vaginal discomfort, vaginal infection, bleeding, groin pain, incomplete bladder emptying and pain.The other procedure is captured in a separate file.No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: 05/24/2023.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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