Catalog Number PFRA01 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problems
Micturition Urgency (1871); Pain (1994); Urinary Tract Infection (2120)
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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) 2006 and mesh was implanted.It was reported that the patient underwent removal surgery on an unk date.It was reported the patient experienced severe pelvic pain.No additional information was added.
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Manufacturer Narrative
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Date sent to the fda: 12/15/2021.Additional b5 narrative: it was reported that the patient experienced urinary tract infections and urgency following the procedure.It was reported that the patient underwent removal surgery on (b)(6) 2014.Corrected b5 narrative: it was reported that the patient underwent a gynecological surgery on (b)(6) 2006 and mesh was implanted.
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Manufacturer Narrative
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Date sent to the fda: 1/11/2022.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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