Catalog Number TVTS1 |
Device Problem
Material Erosion (1214)
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Patient Problems
Bleeding (1738); Erosion (1750); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Other (for use when an appropriate patient code cannot be identified) (2200); Discharge (2225); Surgical procedure (2357)
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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) 2008 and on (b)(6) 2011 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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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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Manufacturer Narrative
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(b)(4).It was reported that the patient underwent a gynecological procedure and mesh was implanted concurrently with removal of prior mesh implant; due to sui and urgency.It was reported that following insertion the patient experienced unresolved sui from procedures, tenderness, pressure and pain in the lower abdominal area, urinary tracy infections and painful bloody discharge.(b)(4).
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Search Alerts/Recalls
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