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Catalog Number PFRT01 |
Device Problem
Migration (4003)
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Patient Problems
Erosion (1750); Unspecified Infection (1930); Neurological Deficit/Dysfunction (1982); Pain (1994); Discomfort (2330); Not Applicable (3189)
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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.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
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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) 2007 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.No additional information was provided.
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Manufacturer Narrative
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Date sent to fda: 06/04/2020.Additional b5 narrative: it was reported that the patient underwent mesh removal on (b)(6) 2019 due to recurrent bladder infections, bladder dysfunction, and discomfort.
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Search Alerts/Recalls
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