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Model Number 810041B |
Device Problem
Migration (4003)
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Patient Problems
Erosion (1750); Hemorrhage/Bleeding (1888); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Pocket Erosion (2013)
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Event Type
Injury
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Manufacturer Narrative
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This emdr represents supplemental report # 2210968-2014-07031 for previously submitted mdr number 2210968-2014-08882, subject of a litigation complaint summary exemption no.E2013037.The referenced exemption was revoked effective may 15, 2019.The reports previously submitted as part of the exemption were not submitted in a format compatible with the public mdr database (maude)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).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 underwent a gynecological surgical procedure on (b)(6) 2011 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 following insertion the patient experienced incontinence, erosion, extrusion, infection, urinary problems, recurrence, bleeding, and neuromuscular problems.It was reported that the patient underwent mesh revision on (b)(6) 2012 and (b)(6) 2012.No additional information was provided.
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Search Alerts/Recalls
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