Correction made to a3: gender: male (previously submitted as female) correction made to e1: initial reporter phone no.: +011()3053708174 (previously submitted as +011(903)053708174) additional information was added to h4, h6, h10.H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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