Catalog Number TVTS1 |
Device Problem
Material Erosion (1214)
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Patient Problems
Bleeding (1738); Erosion (1750); Pain (1994); Abnormal Vaginal Discharge (2123); 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 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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(b)(40.It was reported that the patient underwent a gynecological procedure and mesh was implanted concurrently with hydrothermal ablation and anterior repair; due to menorrhagia, cystocele and sui.It was reported that following insertion patient experienced bleeding, dyspareunia, and discharge.It was reported that the patient underwent mesh removal on (b)(6) 2009 concurrently with hysterectomy; due to erosion and pelvic pain.It was reported that the patient underwent mesh revision on (b)(6) 2012 and (b)(6) /2013.(b)(4).
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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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Search Alerts/Recalls
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