(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.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
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Date sent to fda: 7/8/2020.H6 patient codes: 3191 - prolapse, vaginal irritation.Additional information: a1, a2, b7, d3, d7, g1, g2.Additional b5 narrative: it was reported that the patient experienced recurrent prolapse, and urinary tract infections, vaginal irritation, itching following the procedure.It was reported that the patient underwent removal surgery on (b)(6)2019.
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