Device was used for treatment, not diagnosis.Additional narrative: no patient involvement reported.Event date: unknown.Additional product code: fsm/tray,surgical instrument.Device is an instrument and is not implanted/explanted.Device history records was conducted.The report indicates that the manufacturing location: (b)(4), manufacturing date: 24.Aug.2006, no ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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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