Catalog Number TVTS4 |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problems
Erosion (1750); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Scarring (2061); 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.
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Event Description
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It was reported by an attorney that the patient underwent a gynecological procedure on an unknown date 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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In addition, a device history review has been inserted into the file.This review indicates that there was no quality concerns associated with the manufacturing process.
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Manufacturer Narrative
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It was reported that following insertion the patient experienced infection, urinary problems and vaginal scarring.No additional information was provided.
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Manufacturer Narrative
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It was reported that patient underwent mesh removal on (b)(6)2017 due to incontinence.
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Search Alerts/Recalls
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