Device used for treatment, not diagnosis.(b)(4).Explant date: not explanted.Device is not expected to be returned for manufacturer review/investigation.(b)(6).(b)(4): this event will be captured as use error.The severity of this event was categorized as moderate.Moderate was defined as mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention/therapy required.(b)(4): there is no allegation at the time of this review that the product malfunctioned and the reported event is likely a result of a technical issue.This event will be captured as use error.Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received.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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