MEDLINE

Additional Manufacturer Narrative

PER THE REPORT, "CUSTOMER WOULD LIKE TO RETURN THIS ITEM STATING IT IS DEFECTIVE AND THAT THEY CANNOT HEAR ANYTHING OUT OF IT." DUE DILIGENCE HAS BEEN COMPLETED. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE CUSTOMER CONTACT WAS UNABLE OR UNWILLING TO PROVIDE FURTHER INCIDENT DETAILS TO THE MANUFACTURER. THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, OR FOLLOW UP CARE. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

Description of Event or Problem

PER THE REPORT, "CUSTOMER WOULD LIKE TO RETURN THIS ITEM STATING IT IS DEFECTIVE AND THAT THEY CANNOT HEAR ANYTHING OUT OF IT."