Catalog Number 4350 |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problems
Erosion (1750); Pain (1994); No Code Available (3191)
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Event Type
Injury
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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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Event Description
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It was reported by an attorney that the patient underwent a gynecological procedure on (b)(6) 2013, and a 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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It was reported that following insertion the patient experienced urinary problems and recurrence.It was reported that patient concurrently underwent robotic-assisted sacral colpopexy and cystoscopy.
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Search Alerts/Recalls
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