Device used for treatment, not diagnosis.(b)(4).Original implant date was sometime in (b)(6) 2010 in (b)(6).Device is not expected to be returned for manufacturer review/investigation.The patient felt that the device was rubbing and felt she may have an allergic reaction to the device.Should further information become available this determination will be reviewed accordingly.Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received.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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