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Catalog Number PFRT01 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problems
Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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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.
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Event Description
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It was reported by an attorney that the patient underwent a pelvic floor repair, vaginal hysterectomy, and sacro-spinal vaginal suspension on (b)(6) 2008 and mesh was implanted.It was reported that the patient experienced pain in her back and right side of her body and issues with voiding her bladder.No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: 11/21/2022.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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