Correction b3, d4.B3: the issue occurred on unspecified dates in october (omitted on initial).D4: concomitant products (added additional, omitted on initial).Additional information was added to h6 and h10.H10: the device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.A batch review was performed on the suspect lot (which was manufactured on 02/09/2021) and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
|