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Catalog Number TVTS4 |
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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Manufacturer Narrative
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Product complaint # (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.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.This event was previously submitted under ethicon mdr summary reporting exemption e2013037.Initial psr reporting period: october 1, 2015 through november 30, 2015.Psr submission number: 2210968-2015-13970.Psr report identifier: 2210968-2015-14882.All event details will now be captured via emdr report number.
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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) 2012 and mesh was implanted.It was reported that the patient experienced pain, erosion of her internal bodily tissue and other injuries following the procedure.It was reported that the patient previously underwent a gynecological surgical procedure on (b)(6) 2009 and mesh was implanted.It was reported that the patient 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.No additional information was provided.
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Search Alerts/Recalls
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