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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVAINCU THE INVAINCU RED LED FACE DEVICE; LIGHT BASED OVER THE COUNTER WRINKLE REDUCTION
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INVAINCU THE INVAINCU RED LED FACE DEVICE; LIGHT BASED OVER THE COUNTER WRINKLE REDUCTION Back to Search Results
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Erythema (1840)
Event Date 08/19/2021
Event Type  malfunction  
Event Description
Went to a soap store called (b)(6).The sales person showed me some soap, then rubbed me with a special cream, then used a invaincu red led anti-aging device, that states it is fda approved on the box.The accelerate the process and tried to sell me the unit for (b)(6) and other products in the skin care line as the red led was on my arm.I said no and asked to remove the therapy light and was then told i could get a facial that included the light, i said no and left.Later on that day, my face became really red, and i did not understand why if i never left the casino.I went back to the soap store and they were closed.I put some cortisone cream on and that worked with the redness.My arm was better the next day.I did not go back.(620-730 nm wavelength), thermal therapy (~105f), reduces hormone levels, relieves joint and muscle pain.Heals wounds.Fda safety report id# (b)(4).
 
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Brand Name
THE INVAINCU RED LED FACE DEVICE
Type of Device
LIGHT BASED OVER THE COUNTER WRINKLE REDUCTION
Manufacturer (Section D)
INVAINCU
20725 prairie street
chatsworth CA 91311
MDR Report Key12377342
MDR Text Key268940454
Report NumberMW5103540
Device Sequence Number1
Product Code OHS
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 08/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Was Device Available for Evaluation? No
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age55 YR
Patient Weight28
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