Catalog Number PFRP01 |
Device Problem
Material Erosion (1214)
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Patient Problems
Erosion (1750); Pain (1994); Scar Tissue (2060); Other (for use when an appropriate patient code cannot be identified) (2200); Hernia (2240); 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) 2009 and mesh were 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.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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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 procedure and mesh was implanted due to stress urinary incontinence and rectocele.It was reported that following insertion the patient experienced pain, dyspareunia, vaginal scarring, bowel problems and other outcomes following the procedure.It was reported that the patient underwent mesh excision on (b)(6) 2009 due to pain and bowel problems.The patient underwent mesh excision due to pain, bowel problems and dyspareunia in 2009.(b)(4).
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Manufacturer Narrative
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(b)(4).It was reported by an attorney that the patient underwent a gynecological procedure on (b)(6) 2009 and a mesh was implanted.It was reported that patient underwent excision of posterior vaginal mesh, posterior colporrhaphy, exam under anesthesia on (b)(6) 2010, due to pelvic pain, retained vaginal mesh, defecatory dysfunction.No additional information was provided.
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Manufacturer Narrative
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It was reported by an attorney that the patient underwent a gynecological procedure on (b)(6) 2009, and a mesh was implanted.It was reported that patient underwent reduction and repair of incisional hernia using c-qur mesh on (b)(6) 2011, due to incisional hernia.No additional information was provided.
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Search Alerts/Recalls
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