ETHICON INC. TENSION FREE VAGINAL TAPE - SECUR; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
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Catalog Number TVTS |
Device Problem
Migration (4003)
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Patient Problems
Erosion (1750); Micturition Urgency (1871); Incontinence (1928); Pain (1994); Abnormal Vaginal Discharge (2123); Urinary Frequency (2275); Discomfort (2330)
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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 procedure on (b)(6) 2008 and mesh was implanted.It was reported that the patient experienced discomfort, dyspareunia, urinary frequency, urgency, mixed incontinence, vaginal discharge with foul odor, pain, and erosion of her internal bodily tissue following the procedure.It was reported that the patient has undergone multiple surgeries and revisionary procedures.No additional information was provided.
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Manufacturer Narrative
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Product complaint #: (b)(4).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 event was previously submitted under ethicon mdr summary reporting exemption e2013037.Initial psr reporting period: august 1, 2016 through september 30, 2016.Psr submission number: 2210968-2016-33216.Psr report identifier: 2210968-2016-32364.All event details will now be captured via emdr report number 2210968-2022-02992.
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Search Alerts/Recalls
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