Catalog Number TVTS4 |
Device Problem
Material Erosion (1214)
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Patient Problems
Erosion (1750); Pain (1994); Surgical procedure (2357)
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Event Type
Injury
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Manufacturer Narrative
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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 the patient underwent a gynecological surgical procedure on (b)(6) 2010 and mesh was implanted concurrently with lavh/bso due to symptomatic uterine prolapse and pelvic adhesions.
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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 pelvic organ prolapse, cystocele and rectocele on (b)(6) 2010 and mesh was implanted.It was also reported that she experienced pain, dyspareunia, erosion of her internal bodily tissue and other injuries following the procedure.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).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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Search Alerts/Recalls
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