Additional narrative: device was used for treatment, not diagnosis.Information not provided by reporter device not explanted.(b)(6).The investigation could not be completed; no conclusion could be drawn, as no product was received.Dhr review ¿ manufacturing location: (b)(4).Manufacturing date: 20.April 2012.Expiry date: 01.April 2015.No anomalies were detected during device history record review.No ncrs were generated during production.Review of the device history record 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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