This device was not returned to mmdg for evaluation.A dhr review was completed and found no non-conformances.Because the device was not returned to mmdg for evaluation, an investigation could not be completed.This report is being filed because there is indication that the event occurred while the device was in use by a pediatric patient (under 18).Per our procedures all reports of this type of event that involve a pediatric patient are considered reportable.It will be updated if the device is returned to mmdg.
|