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Catalog Number 810041A |
Device Problem
Migration (4003)
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Patient Problems
Erosion (1750); Pain (1994); Blood Loss (2597)
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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 a gynecological surgical procedure on (b)(6) 2014 and mesh was implanted, due to stress urinary incontinence.It was reported that she experienced pain, erosion, bleeding and other injuries following the procedure.It was reported that the patient underwent surgery on (b)(6) 2020.No additional information was provided.
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Manufacturer Narrative
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Date sent to fda: (b)(6) 2020.Additional information: a2, d1, d4, g5, h4.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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