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Model Number TVTRL |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problems
Incontinence (1928); Pain (1994); Urinary Tract Infection (2120)
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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 surgical procedure on (b)(6) 2012 and mesh was implanted.It was reported that the patient experienced bladder incontinence, pain during intercourse, and frequent bladder and urine infections.No additional information was provided.
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Manufacturer Narrative
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To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.
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Manufacturer Narrative
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Date sent to the fda: 11/20/2022.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
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Search Alerts/Recalls
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