ETHICON INC. TENSION FREE VAGINAL TAPE - SECUR; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
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Catalog Number TVTS |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Incontinence (1928); Pain (1994); Blood Loss (2597)
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Event Type
Injury
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Manufacturer Narrative
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(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.A review of the manufacturing records was performed and indicates that there were no quality concerns associated with the manufacturing process.
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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 were implanted.It was reported that the patient experienced sui,pain,bleeding, infection.No additional information was provided.
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Search Alerts/Recalls
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