Catalog Number PMM3 |
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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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 in (b)(6) 2012 and mesh was implanted.It was reported that the patient was previously implanted with mesh on (b)(6) 2010.It was reported that she experienced pain, erosion of her internal bodily tissue and other injuries following the procedure.No additional information was provided.
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Manufacturer Narrative
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Date sent to fda: 06/29/2020.
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Manufacturer Narrative
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Date sent to fda: 07/01/2020.Additional information: a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
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Search Alerts/Recalls
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