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Catalog Number TVTS4 |
Device Problem
Material Erosion (1214)
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Patient Problems
Bleeding (1738); Erosion (1750); Unspecified Infection (1930); Neurological Deficit/Dysfunction (1982); Internal Organ Perforation (1987); 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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Event Description
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It was reported by an attorney that the patient underwent a gynecological procedure to treat stress urinary incontinence on (b)(6) 2007 and mesh was implanted with concurrent cystoscopy.It was also reported that she experienced pain, erosion of her internal bodily tissue, extrusion, infection, urinary/bowel problems, organ perforation, recurrence, bleeding, dyspareunia, vaginal scarring and numbness in legs.It was further 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).It was reported that the patient underwent a gynecological procedure and mesh was implanted along with concurrent cystoscopy due to sui.It was reported that following insertion the patient experienced pain, extrusion, infection, urinary/bowel problems, organ perforation, recurrence, bleeding, dyspareunia, vaginal scarring and numbness in legs.A review criteria.Of the batch manufacturing records was conducted and the batch met all finished goods release.
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Search Alerts/Recalls
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