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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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(b)(4).The patient underwent mesh implantation in order to treat a rectocele, a cystocele, an enterocele, and stress urinary incontinence.The patient underwent the concurrent procedures of anterior/ posterior enterocele repair, colpopexy, suprapubic catheter placement, and cystoscopy during mesh implantation.
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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 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): 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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Additional narrative: it was reported that following insertion the patient experienced infection, urinary/bowel problems, recurrence, and dyspareunia.No additional information was provided.
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Search Alerts/Recalls
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