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Model Number GPSL |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Injury
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Event Description
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It was reported that the patient underwent a (b)(6) surgical procedure on (b)(6) 2008 and (b)(6) was (b)(6) , concurrently with total (b)(6).It was reported that the patient underwent a (b)(6) surgical procedure on (b)(6) 2009 and gynemesh was implanted.It was reported that patient underwent mesh removal on (b)(6) 2008, (b)(6) 2009 and (b)(6) 2012.No additional information was provided.
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Manufacturer Narrative
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(b)(4).This emdr represents supplemental report #(b)(4) for previously submitted mdr number 2210968-2018-70989, subject of a litigation complaint summary exemption no.E2013037.The referenced exemption was revoked effective (b)(6) 2019.The reports previously submitted as part of the exemption were not submitted in a format compatible with the public mdr database (maude)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.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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