Catalog Number TVTS4 |
Device Problem
Material Erosion (1214)
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Patient Problems
Erosion (1750); Pain (1994); 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 by an attorney that the patient underwent a gynecological procedure on (b)(6) 2009 and mesh was 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).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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It was reported that following insertion the patient experienced stress urinary incontinence, urinary retention, dyspareunia, recurrence, pelvic/rectal pain and pressure.
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Manufacturer Narrative
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(b)(4) overactive bladder.It was reported that the patient underwent interstim lead placement, battery placement and programming, and fluoroscopy due to overactive bladder with urge incontinence on 8/19/2009 by christopher h.Roberts, md at freeman health system.
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Search Alerts/Recalls
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