Additional narrative: patient information is unknown.Unknown when infection started; it was noted on (b)(6) 2015.(b)(4).Device has not been explanted.(b)(6).Manufacturing location: (b)(4).Manufacturing date: 13december2013.Expiry date: 01december2023.No non-conformance reports 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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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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