Device not explanted.(b)(6).The investigation could not be completed; no conclusion could be drawn, as no product was received.Manufacturing location: (b)(6).Manufacturing date: (b)(6)2012.Expiry date: (b)(6) 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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