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Catalog Number GPSXL334 |
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.Psr-66074 represents the adverse event which occurred on (b)(6) 2012.Mwr-20072020-0000768782 represents the adverse event which occurred on (b)(6) 2016.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
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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)(4) 2011 and mesh was implanted.It was reported that the patient experienced prolapse on (b)(4) 2012 and underwent removal surgery with a cystocele repair and rectocele repair.It was reported that the patient experienced mesh exposure and pain with intermittent catheterization, dyspareunia and mixed urinary incontinence, urge incontinence and fecal incontinence on (b)(4) 2016.It was reported that the patient underwent removal surgery of the exposed mesh in the right posterior and apical vagina, a cystoscopy and vaginoscopy on (b)(4) 2016.No additional information was provided.
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Search Alerts/Recalls
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