This emdr represents supplemental report # 2210968-2017-04521 for previously submitted mdr number 2210968-2017-70664, 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The referenced exemption was revoked effective may 15, 2019.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.
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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