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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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Manufacturer Narrative
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This emdr represents supplemental report # psr-60870 for previously submitted mdr number 2210968-2018-76762, subject of a litigation complaint summary exemption no.E2013037.The referenced exemption was revoked effective (b)(6) 2019.The reports previously submitted as part of the exemption were not submitted in a format compatible with the public mdr database (maude)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).
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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) 2010 and ethicon gynemesh ps prolene was implanted.It was reported that the patient underwent explant surgery on (b)(6) 2017.No additional information was provided.
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Search Alerts/Recalls
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