Catalog Number TVTS4 |
Device Problem
Other (for use when an appropriate device code cannot be identified) (2203)
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Patient Problems
Micturition Urgency (1871); Incontinence (1928); Pain (1994); Other (for use when an appropriate patient code cannot be identified) (2200)
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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).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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It was reported that the patient underwent a gynecological surgical procedure on (b)(6)2009 and tvt-secure was implanted.No additional information was provided.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.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
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Manufacturer Narrative
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It was reported that following insertion the patient experienced suprapubic pain, incontinence, and urgency.
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Search Alerts/Recalls
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