The device with lot number c01201904740 was manufactured in 2019.The device history record of the complaint lot was reviewed.The lot was inspected and released in compliance with all requirements.No sample was provided by the customer; therefore, an evaluation of the complaint device for deficiency of construction could not be performed.Based on the investigation, no specific assignable cause can be determined as there is limited information.Without a specific assignable cause, no action will be taken at this time.We will continue to monitor trends based on this type of issue.
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