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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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(b)(4).This emdr represents supplemental report # (b)(4) for previously submitted mdr number 2210968-2018-76743, subject of a litigation complaint summary exemption no.E2013037.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) 2006 and mesh was implanted.It was reported that she experienced undisclosed injuries.It was reported that the patient underwent a revision surgery on (b)(6) 2016.No additional information was provided.
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Search Alerts/Recalls
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