Patient initials ¿ (b)(6).Patient age and weight not available for reporting.Device is an instrument and is not implanted / explanted.The investigation could not be completed; no conclusion could be drawn, as no product was received.Dhr review: 314.743 supplier lot#15022-01 / synthes lot#5602756.Release to warehouse date: 20sept2007.Supplier- (b)(4).No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.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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