Device was used for treatment, not diagnosis.
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.
The reporter was not able to provide the associated lot number for this event so the lot numbers provided were j43052 and j43054 and it is unknown which of the two devices is associated with the reported event.
|