Device was used for treatment, not diagnosis.Patient id, age/date of birth, weight and ethnicity/race were not provided for reporting.The lot number was not provided for reporting.(b)(4).Expiration date= na.Lot number = ni.Device is not expected to be returned for manufacturer review/investigation.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without the lot number.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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