Device Problem
Migration (4003)
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Patient Problems
Erosion (1750); Pain (1994)
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Event Type
Injury
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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 an unknown date and mesh was implanted.It was reported that she experienced pain, erosion of her internal bodily tissue and other injuries following the procedure.It was reported that the patient has undergone multiple surgeries and revisionary procedures.The patient had had a previous mesh implanted on (b)(6) 2007 which is captured in separate file.No additional information was provided.
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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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Manufacturer Narrative
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Date sent to the fda: 11/16/2022.
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Search Alerts/Recalls
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