Catalog Number TVTRL |
Device Problems
Migration or Expulsion of Device (1395); Other (for use when an appropriate device code cannot be identified) (2203)
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Patient Problems
Erosion (1750); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Other (for use when an appropriate patient code cannot be identified) (2200); Surgical procedure (2357); No Code Available (3191)
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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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(b)(4).It was reported by an attorney that the patient underwent a gynecological procedure on 8/03/12 and a mesh was implanted.No additional information was provided.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 by an attorney that the patient underwent a gynecological procedure on (b)(6) 2012, and a mesh was implanted due to sui.It was reported that following insertion the patient experience infection, dyspareunia and other.No additional information was provided.
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Manufacturer Narrative
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It was reported that the patient underwent cystoscopy on (b)(6) 2013 by dr.(b)(6) due to recurring urinary incontinence.
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Search Alerts/Recalls
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