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