Device Problem
Material Erosion (1214)
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Patient Problems
Erosion (1750); Micturition Urgency (1871); Unspecified Infection (1930); Neurological Deficit/Dysfunction (1982); Pain (1994); Other (for use when an appropriate patient code cannot be identified) (2200); Urinary Frequency (2275); Surgical procedure (2357)
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Event Type
Injury
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Event Description
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It was reported that the patient underwent a gynecological surgical procedure on (b)(6) 2011 and mesh was implanted due to sui.It was reported that following insertion the patient experienced pain, erosion of her internal bodily tissue, infection, urinary problems, recurrence and neuromuscular problems.It was reported that the patient has undergone multiple surgeries and revisionary procedures, including an excision of mesh on (b)(6) 2012 due to erosion and risk of organ perforation.
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Manufacturer Narrative
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(b)(4).Conclusion: 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)(4).It was reported by an attorney that the patient underwent a gynecological procedure on (b)(6) 2011 and a mesh was implanted.It was reported that the patient underwent interstim lead and lmpluse generator placement with intraoperative fluoroscopy on (b)(6) 2012, due to urgency and frequency.No additional information was provided.
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Manufacturer Narrative
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It was reported that the patient concurrently underwent cystoscopy, bladder biopsies and retrograde pyelogram ((b)(6) 2009), transvaginal tape/gynecare with cystoscopy ((b)(6) 20011).
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Manufacturer Narrative
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Search Alerts/Recalls
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