It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2009 and mesh was implanted.It was reported that the patient experienced uti, back pain, groin pain, hip pain, leg pain, buttock pain, sciatica, vaginal discharge, thigh pain, vaginal bleeding, abdominal pain, leg numbness, menorrhagia, urinary incontinence, constipation, dyspareunia, diarrhea, urgency, urge incontinence, frequency, bowel urgency, bloating, fibromyalgia, arthritis, pelvic pain, cystocele, rectocele, vaginal pain, peri-anal pain, fecal looseness, nocturia, dysuria and thrush.No additional information was provided.
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Date sent to the fda: 3/8/2024.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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Date sent to the fda: 3/14/2024.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 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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