Date of event: (b)(6) 2017.Date of report: 03july2019.The manufacturer¿s international service technician confirmed the reported issue.Multiple attempts were made to follow-up with the customer to obtain additional information however, there was no response.If additional information is received at a later date, the complaint will be re-opened and re-evaluated accordingly.This mdr has been reassessed as reportable after a request from the fda on march 1, 2019 to review complaints from 29 nov 2017 to 29 nov 2018.As this has been reassessed, it will appear to be a late mdr.
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