Catalog Number TVTS4 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problems
Incontinence (1928); Pain (1994); Urinary Tract Infection (2120); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4) undisclosed injuries.To date, the device has not been returned.If the product is returned for evaluation, any further info derived from the evaluation will be submitted in a supplemental 3500a form.
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Event Description
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It was reported by an attorney that the patient underwent a gynecological surgical procedure on an undisclosed date and mesh was implanted.It was reported that she experienced undisclosed injuries.ࠎo additional information was provided.
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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 mesh was implanted.It was reported that following insertion the patient experienced stress incontinence and urinary tract infection unspecified.It was reported that the patient underwent mesh removal on (b)(6) 2013 by (b)(6).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 dyspareunia.
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Search Alerts/Recalls
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