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Catalog Number TVTS4 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).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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Event Description
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It was reported by an attorney that the patient underwent gynecological procedure on (b)(6) 2006 and mesh was implanted due to stress urinary incontinence.It was reported that patient experienced undisclosed injury.No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: 12/18/2020.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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