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Catalog Number 810041A |
Device Problem
Other (for use when an appropriate device code cannot be identified) (2203)
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Patient Problems
Neurological Deficit/Dysfunction (1982); Scarring (2061); Other (for use when an appropriate patient code cannot be identified) (2200); 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 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.
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Manufacturer Narrative
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It was reported that the patient underwent a gynecological procedure and mesh was implanted concurrently with tvh, anterior and posterior colporrhaphy, mccall culdoplasty, cystoscopy and perineoplasty.
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Manufacturer Narrative
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(b)(4).It was reported that following insertion the patient experienced urinary problems, bowel problems, recurrence, neuromuscular problems, vaginal scarring and dyspareunia.
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Search Alerts/Recalls
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