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Catalog Number PFRT01 |
Device Problem
Migration (4003)
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Patient Problems
Erosion (1750); Foreign Body Reaction (1868); Fibrosis (3167); 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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This emdr represents supplemental report # (b)(4) for previously submitted mdr number 2210968-2018-75205.Subject of a litigation complaint summary exemption no. e2013037. the referenced exemption was revoked effective may 15, 2019. the reports previously submitted as part of the exemption were not submitted in a format compatible with the public mdr database (maude) and are available through fda¿s mdr data files webpage, at https://www.Fda.Gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/mdr-data-files#asr. therefore, this report does not represent a new reportable event.The information included in this report was submitted outside the required timeframe due to the extended use of exemption e2013037 beyond its revoke date, as documented under (b)(4) (ethicon¿s internal reference number).(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 the patient underwent a mesh removal surgery on (b)(6) 2016 due to mesh exposure, rectocele and enterocele.It was reported that the patient had fibrosis and foreign body granulomatous reaction.No additional information was provided.
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Search Alerts/Recalls
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