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Catalog Number TVTS4 |
Device Problem
Migration (4003)
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Patient Problems
Erosion (1750); Not Applicable (3189)
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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 surgery on (b)(6) 2008 and mesh was implanted, due to stress urinary incontinence, rectocele and sexual dysfunction.It was reported that the patient underwent excision of mesh on (b)(6) 2017 due to erosion of mid urethral sling to the urethra.No additional information was provided.
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Manufacturer Narrative
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Date sent to fda: 10/15/2020.Additional information: d1, d2b, 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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