Agfa submitted mdr report #1225058-2010-00001 to the fda on june 7, 2010, for a site in the us.A 14th occurrence is being reported for the same issue/same device: impax cv results management administration tool (rmat).This is an internal discovery determined during the implementation of the associated problem correction plan, rmat verification, as reported in fda z-2112-10.Within this occurrence are 174 different study dates in which an individual mdr report will be submitted for each associated study date and medical record number/s (mrn) identified.
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