Device was used for treatment, not diagnosis.Patient information was not provided for reporting.Concomitant medical products: upc: (b)(4).Lot number : ni.Exp date: na.Udi: (b)(4).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 lot number.This is 2 of 2 med-watches being submitted for (unknown quantity of flosser heads) were involved in this event.See medwatch 8041101-2020-00016 for initial use of flosser head.The same patient is represented in each medwatch.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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