Adverse Events; Complications - Bioventus EXOGEN Manual Del Usuario

Adverse Events

Unlike conventional (physical therapy)
ultrasound devices, EXOGEN is incapable of
producing harmful temperature increases in
body tissue . The ultrasound output intensity
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of EXOGEN is 30 mW/cm and is typically only
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1% to 5% of the output intensity of conventional
therapeutic ultrasound devices. The ultrasound
intensity is comparable to diagnostic ultrasound
(1 to 50 mW/cm ), such as the intensities used
2
in obstetrical sonogram procedures (fetal
monitoring). In addition, there is no evidence
of non-thermal adverse effects (cavitation).

Complications

No device-related adverse reactions or medical
complications related to the use of EXOGEN
were reported during the clinical studies. Some
patients have experienced mild skin irritation
caused by skin sensitivity to the gel. If you feel
your skin is sensitive to the gel, you may change
the gel to mineral oil or glycerin. In the distal
radius study, one patient complained of pain
during treatment but they no longer had the pain
by the next follow up visit; and one patient,
complaining of pain, withdrew from the study.
Labeling LBL-000319 [D] RELEASED
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