Catalog Number TVTSECUNK |
Device Problem
Other (for use when an appropriate device code cannot be identified) (2203)
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Patient Problems
Incontinence (1928); Pain (1994); Other (for use when an appropriate patient code cannot be identified) (2200); Blood Loss (2597)
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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 an unknown date and an unknown mesh was implanted.It was reported that the patient experienced unspecified complications.No additional information has been 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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Date sent to the fda: 03/29/2017.
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Manufacturer Narrative
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Date sent to the fda: 04/26/2017.It was reported that the patient underwent gynecological procedure on (b)(6) 2007 and tvt secure was implanted.It was reported that following the procedure the patient experienced pain, fecal incontinence, blood in the urine, continued of urinary incontinence.
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Search Alerts/Recalls
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