Miramar Miradry MD4000-MC, User Manual, Page: 8 / 44

LB0261 Rev A 01/2018 © Miramar Labs, Inc. 2018, Confidential Information of Miramar Labs, Inc. Page 8
5. CONTRAINDICATIONS
The miraDry System is contraindicated in people:
o
With heart pacemakers and other electronic device implants.
o
Who need supplemental oxygen.
o
With known resistance to or history of intolerance of local anesthesia including lidocaine
and epinephrine.
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a
physician.
6. POTENTIAL RISKS
As with any medical device, there are possible risks associated with the use of the miraDry
System. Patients should be monitored closely for symptoms to allow for early intervention.
The most common side effects observed within or near the treatment area follow below. Most of
these side effects can last from a few days to a few weeks following treatment. Others can last
from one to several months or longer as noted.
•
Swelling/tightness in the treated area
•
Discomfort, tenderness or pain in the underarm when touched, usually treatable with non-
prescription medications such as ibuprofen
•
Redness from the device suction
•
Bruising at the numbing injection sites
•
Bumps under the treated area (can last for several months)
•
Temporary altered sensation or tingling in the treated skin and/or upper arm (can last for
several months)
Other less common side effects include:
•
Swelling in the adjacent arm or torso (usually lasting a few days)
•
Hyperpigmentation (darkening of skin) in the treatment area
•
Soreness in the shoulders or arms due to positioning of the arms during the procedure
•
Numbness or tingling in the arm due to the anesthesia (usually lasting less than 24 hours)
•
Shaking due to epinephrine in the anesthesia (usually lasting less than 24 hours)
•
Tight banding in the underarm (gradually resolves)
There have been rare reports of:
•
Altered sweating elsewhere on the body
•
Small blisters/ulcerations or rashes in the treatment area
•
Temporary altered sensation or tingling in the forearm or fingers (can last for several
months)
•
Weakness in the arm or fingers that gradually goes away (but can last for several months)
•
Pain in the arm or fingers that gradually goes away (can last for several months)
•
Pain in the underarm requiring prescription medications
•
Infection/abscess
•
Burns