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Model Number PMII |
Device Problem
Migration (4003)
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Patient Problems
Erosion (1750); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Pain (1994); Hematuria (2558); 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 #2210968-2014-16518 for previously submitted mdr number 2210968-2014-15562 subject of a litigation complaint summary exemption no.E2013037.The referenced exemption was revoked effective may 15, 2019.The reports previously submitted as part of the exemption were not submitted in a format compatible with the public mdr database (maude)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.(b)(4).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) 2005 and mesh was implanted.It was also reported 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 patient has undergone multiple surgeries and revisionary procedures.It was reported that following insertion the patient experienced infection, urinary/bowel problems, recurrence, bleeding, and neuromuscular problems.It was reported that the patient underwent removal surgery on (b)(6) 2017.It was reported that the patient experienced blood in her urine.No additional information was provided.
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Search Alerts/Recalls
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