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Catalog Number PFRT02 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erosion (1750); Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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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) 2009 and mesh was implanted, due to cystocele, rectocele, and urinary incontinence.It was reported that the patient underwent partial revision surgery on (b)(6) 2021.It was reported that the patient experienced undisclosed adverse event.No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: 1/20/2022.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
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Manufacturer Narrative
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Date sent to the fda: 8/16/2022.Additional b5 narrative: it was reported that the patient experienced pain, and erosion.
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Search Alerts/Recalls
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