Device was used for treatment, not diagnosis.Patient age at time of event, weight, and ethnicity and race was not provided for reporting.Upc #: (b)(4), lot #: 1326s, exp date: na udi #: (b)(4).Device is not expected to be returned for manufacturer review/investigation (b)(4).Device history records review was completed.No non-conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition and product was manufactured per specification.The product was manufactured on may 11, 2016.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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