Catalog Number TVTS1 |
Device Problem
Material Erosion (1214)
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Patient Problems
Erosion (1750); Unspecified Infection (1930); Neurological Deficit/Dysfunction (1982); Pain (1994); Scar Tissue (2060); 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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Manufacturer Narrative
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(b)(4).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 the patient underwent a gynecological procedure and mesh was implanted due to stress urinary incontinence and pelvic organ prolapse.It was reported that following insertion the patient experienced infection, urinary/bowel problems, recurrence, dyspareunia, neuromuscular problems and vaginal scarring.It was reported that the patient underwent excision of mesh on (b)(6) 2009 due to extrusion.It was reported that the patient underwent excision of mesh on (b)(6) 2012 due to erosion.(b)(4).
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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 mesh were 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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(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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Search Alerts/Recalls
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