Catalog Number TVTS1 |
Device Problem
Material Erosion (1214)
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Patient Problems
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 that mesh was implanted on (b)(6) 2007 due to stress urinary incontinence.
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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) 2009 and mesh was implanted.It was reported that she experienced pain, erosion of her internal bodily tissue and other injuries 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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It was also reported that the patient underwent mesh revision/removal on (b)(6) 2008 due to vaginal mesh erosion, dyspareunia, and pelvic pain.No additional information was provided.(b)(4).
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Manufacturer Narrative
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(b)(4).Conclusion: no conclusion can be drawn at this time.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.
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Manufacturer Narrative
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(b)(4).A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
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Search Alerts/Recalls
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