Device was used for treatment, not diagnosis.(b)(4), lot number = ni, exp date: na.Device is not expected to be returned for manufacturer review/investigation.Concomitant medical products: consumer still on drugs for following concomitant medical products and therapy dates: gabapentin300mg 3x per day, flomax, prazosin 4mg, propranolol 10mg 3x per day, kcl 10meq 2 tablets 2x per day, furosemide, pravastatin, famotidine prn, omeprazole 20mg 1x per day, baclofen 10mg 3xper day, albuterol, atenolol 100 2x per day, allopurinol, magnesium 500mg 2x per day, metformin 500mg 2 tabs qd at supper, imdur, nitroglycerin sl, zonisamide 50mg, melatonin, asa 81 1x per day, nifedipine 2x per day, mtv 1x per day, iron.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without lot number.(b)(4).This is two of two medwatches being submitted as consumer reported adverse events for both left and right foot.See medwatch 8041154-2019-00067 (left foot) and 8041154-2019-00068 (right foot).The same patient is represented in each medwatch.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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