ETHICON INC. TENSION FREE VAGINAL TAPE - SECUR; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
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Catalog Number TVTS |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
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Patient Problems
Erosion (1750); Pain (1994); Injury (2348); Blood Loss (2597)
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Event Type
Injury
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Manufacturer Narrative
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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.
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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) 2008 and two meshes were implanted.It was reported that the patient experienced undisclosed adverse event.No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: 4/29/2020.Additional h6 patient code: 3189 - surgical intervention.Additional b5 narrative: it was reported that the patient underwent anterior and posterior mesh removal on (b)(6) 2018 due to pain, bleeding and mesh erosion.
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Search Alerts/Recalls
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