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Catalog Number TVTS4 |
Device Problem
Other (for use when an appropriate device code cannot be identified) (2203)
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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 Date 11/15/2007 |
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) 2007 and a mesh was implanted due to urinary incontinence.The patient suffered from pain and dyspareunia and has undergone various surgical procedures in an attempt to remove the mesh, experiences physical, psychological and emotional pain, suffering and has sustained permanent and debilitating injuries.(b)(6) for report on the second tvts device lot 3190447.
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Manufacturer Narrative
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(b)(4).Conclusion code: 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).It was reported by an attorney that the patient underwent a gynecological procedure on (b)(6) 2007, and a mesh was implanted due to sui.It was reported that the patient underwent mesh revision on (b)(6) 2008, due to mesh erosion.It was reported that the patient underwent mesh removal on (b)(6) 2010, due to mesh erosion and dyspareunia.It was reported that the patient underwent mesh revision on (b)(6) 2012, due to dyspareunia and vaginal pain.No additional information was provided.In addition, 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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