Catalog Number TVTS1 |
Device Problem
Material Erosion (1214)
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Patient Problems
Bleeding (1738); Erosion (1750); Pain (1994); 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 mesh excision on (b)(6) 2010 due to mesh erosion.
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Manufacturer Narrative
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It was reported that the patient underwent a transvaginal hysterectomy, and trimming of mesh from vaginal wall on 2008.Also, it was reported that the patient underwent a trimming of mesh from vaginal wall on 2009.
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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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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 was implanted along with transvaginal hysterectomy due to abnormal uterine bleeding.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, including a mesh removal on (b)(6) 2010 due to erosion.No additional information was provided.
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Search Alerts/Recalls
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