Catalog Number TVTS4 |
Device Problem
Material Erosion (1214)
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Patient Problems
Erosion (1750); Unspecified Infection (1930); Pain (1994); Other (for use when an appropriate patient code cannot be identified) (2200); Surgical procedure (2357); No Code Available (3191)
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Event Type
Injury
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Event Description
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It was reported that the patient underwent a gynecological surgical procedure on (b)(6) 2007 and mesh was implanted.It was reported that following insertion the patient 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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Manufacturer Narrative
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It was reported that the patient underwent a gynecological procedure on (b)(6) 2007 and a mesh was implanted due to sui.
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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.It was reported that following insertion the patient experienced erosion, urinary problems and recurrence.It was reported that patient underwent mesh revision on (b)(6) 2013 due to extrusion.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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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.It was reported that patient underwent mesh revision on (b)(6) 2013 due to extrusion.No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: 02/16/2017.
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Manufacturer Narrative
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Date sent to the fda: 02/16/2017.It was reported that following insertion the patient experienced infection and bowel problems.
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Search Alerts/Recalls
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