Device Problem
Material Erosion (1214)
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Patient Problems
Erosion (1750); Incontinence (1928); 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) 2004 and an unknown mesh was implanted.It was reported that the patient 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 by an attorney that the patient underwent a gynecological procedure on (b)(6) 2004 and a mesh was implanted due to sui and urethral hypermobility.It was reported that patient underwent periurethral durasphere injection on (b)(6) 2010, due to sui and vaginal wall prolapse.No additional information was provided.
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Manufacturer Narrative
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Date sent to fda: 04/07/2016.
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Search Alerts/Recalls
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