No reported patient involvement.Device is an instrument and is not implanted or explanted.The complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(6).The investigation could not be completed; no conclusion could be drawn as no product was received.Device history record review: manufacturing date: december 12, 1998 the device history record review could not be performed as the records could not be identified due to the age of the instrument (over 18 years old).Device 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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