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Catalog Number PFRT01 |
Device Problem
Migration (4003)
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Patient Problems
Erosion (1750); Inflammation (1932); 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.In addition, a review of the manufacturing records was performed and indicates that there were no quality concerns associated with the manufacturing process. .
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Event Description
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It was reported by an attorney that the patient experienced sui, cystocele, rectocele, enterocele, and vaginal prolapse.It was reported that she underwent a gynecological surgical procedure on (b)(6) 2007 and mesh and mesh were implanted.It was reported that patient underwent revision of mesh on (b)(6) 2008 due to vaginitis and mesh erosion.No additional information was provided.
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Search Alerts/Recalls
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