Catalog Number TVTS4 |
Device Problems
Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bleeding (1738); Erosion (1750); Unspecified Infection (1930); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Other (for use when an appropriate patient code cannot be identified) (2200); Surgical procedure (2357)
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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 to treat stress urinary incontinence and symptomatic rectocele on (b)(6) 2008 and mesh was implanted along with concurrent posterior colporrhaphy.It was also reported that she experienced pain, infection, bleeding, recurrence, urinary/bowel problems, erosion of her internal bodily tissue and other injuries following the procedure.It was further 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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(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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Manufacturer Narrative
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(b)(4): it was reported that patient underwent stage interstim on (b)(6) 2011.
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Manufacturer Narrative
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(b)(4).
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Manufacturer Narrative
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Date sent to fda: 7/13/2018 additional narrative: it was reported that the patient experienced urinary tract infection and urinary retention.No additional information was provided.
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Search Alerts/Recalls
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