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Catalog Number PFRA02 |
Device Problem
Migration (4003)
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Patient Problems
Incontinence (1928); Pain (1994); Tissue Damage (2104)
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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) 2009 and two mesh were implanted.It was reported that the patient underwent concurrent vaginal hysterectomy and bilateral salpingo-oophorectomy procedure.It was reported that following insertion the patient experienced incomplete bladder emptying, vaginal atrophy, pelvic pain, incontinence and bladder muscle dysfunction.It was reported that the patient underwent excision of mesh on (b)(6) 2017 due to urethral obstruction and mesh erosion.No additional information was provided.
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Manufacturer Narrative
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Date sent to fda: 10/14/2020.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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