ETHICON INC. TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
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Device Problem
Migration (4003)
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Patient Problems
Abdominal Pain (1685); Purulent Discharge (1812); Micturition Urgency (1871); Hemorrhage/Bleeding (1888); Pain (1994); Abdominal Distention (2601)
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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 dyspareunia, lower abdominal pain, bloating, pelvic pain, urgency and discharge.No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: (b)(6) 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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