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Catalog Number TVTS4 |
Device Problem
Material Erosion (1214)
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Patient Problems
Bleeding (1738); Erosion (1750); Pain (1994); Other (for use when an appropriate patient code cannot be identified) (2200); Surgical procedure (2357)
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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 also reported that she experienced pain, erosion of her internal bodily tissue and other injuries following the procedure.It was further 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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(b)(4).No conclusion can be drawn at this time.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
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Manufacturer Narrative
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(b)(4).It was reported that following insertion the patient experienced pain, erosion, extrusion, urinary problems, recurrence, bleeding, dyspareunia.It was reported that the patient underwent resection of exposed prolene vaginal graft followed by primarily closure of the vagina on (b)(6) 2009 due to vaginal graft erosion following mesh anterior colporrhaphy.No additional information was provided.
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Search Alerts/Recalls
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