This message was posted by a user wishing to remain anonymous
Need your advice ,
There was reporting and recall carried out under 1003 and 1004 to the FDA 10 years ago. The field correction was carried out for other markets too - Australia , EU , Canada however it was considered that the risk was acceptable ( remote probability) and the event was not reported to these countries. Now after 10 years , the same complaint has occurred in Australia , the unit was part of the field correction (was inspected as part of the advisory notice, but the correction remained pending because the consignee did not respond). The hazard severity is such that it requires medical intervention so it should have been reportable even then. Now this old unit has been brought back to the facility and has been decommissioned .
What should be the correct approach to deal with this scenario now. For the FDA , I assume we have done everything , and we don't need to do anything now. But I am just confused now what needs to be done for the complaint assessment when it comes to other markets , you cant say its not reportable and then does it mean we need to check the distribution and recall the units which are not corrected on the field ?