Catalog Number PFRA01 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
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Patient Problems
Erosion (1750); Hemorrhage/Bleeding (1888); Pain (1994); Urinary Tract Infection (2120); Prolapse (2475); Insufficient Information (4580)
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Event Type
Injury
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Manufacturer Narrative
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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) 2005 and mesh was implanted.It was reported that the patient experienced undisclosed adverse events.No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: 11/14/2022.
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Manufacturer Narrative
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Date sent to the fda: 01/04/2023.Additional b5 narrative: it was reported that the patient underwent mesh removal on (b)(6) 2022 due to mesh exposure, recurrent vaginal vault prolapse, pain, bleeding and uti.
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Search Alerts/Recalls
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