Device malfunctioned intra-operatively and was not implanted / explanted.
Reporter phone number and email address are unknown.
Device is not distributed in the united states, but is similar to device marketed in the usa.
The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.
A device history records review has been requested.
(b)(4).
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.
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