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Catalog Number TVTS4 |
Device Problem
Material Erosion (1214)
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Patient Problems
Erosion (1750); Other (for use when an appropriate patient code cannot be identified) (2200); Surgical procedure (2357)
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Event Date 05/18/2015 |
Event Type
Injury
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Manufacturer Narrative
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The mesh was excised on (b)(6) 2015.Upon removal of the mesh, partial erosion of the vaginal mesh was noted.
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Event Description
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It was reported that the patient underwent a gynecological procedure on (b)(6) 2007 and mid-urethral sling was implanted.Following the procedure, the patient experienced painful intercourse.On pelvic exam, partial erosion of the graft was found.The patient underwent an excision of exposed part of the graft.Additional information has been requested.
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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.(b)(4).A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.This medwatch report is in response to receipt of voluntary mw 180012-2015-0007.
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Search Alerts/Recalls
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