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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GLOBALMED TECHNOLOGIES CO. OMNILUX CONTOUR; LIGHT BASED OVER THE COUNTER WRINKLE REDUCTION
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GLOBALMED TECHNOLOGIES CO. OMNILUX CONTOUR; LIGHT BASED OVER THE COUNTER WRINKLE REDUCTION Back to Search Results
Lot Number 5223TN
Health Effect - Clinical Code Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event 06/10/2024
Type of Reportable Event Serious Injury
Event or Problem Description
Hair growth on face.I purchased fda approved omnilux contour face mask.I have used it for several months and have realized that i have noticeable hair growth allover my face.Naturally, i had a some peach fuzz on my skin but now the dark hair and some coarse one as well.There seems to be other people having this issue.Contacted omnilux and they confirmed that some have noticed hair growth but this information is not disclosed on their website.I cannot return the product because it is past return date and now i have to pay for hair laser removal.Using product for: anti-aging.Dates of use: (b)(6) 2024.
 
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Brand Name
OMNILUX CONTOUR
Common Device Name
LIGHT BASED OVER THE COUNTER WRINKLE REDUCTION
Manufacturer (Section D)
GLOBALMED TECHNOLOGIES CO.
MDR Report Key19659287
Report NumberMW5156924
Device Sequence Number8332043
Product Code OHS
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Voluntary
Initial Reporter Occupation Patient
Type of Report Initial
Report Date (Section B) 06/27/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Lot Number5223TN
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date07/01/2024
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
AMBIEN; B-COMPLEX; ETODOLAC; METOPROLOL ; REMICADE INFUSION ; TYLENOL ; VIT D3; ZINC ; ZOLOFT
Outcome Attributed to Adverse Event Other;
Patient Age49 YR
Patient SexFemale
Patient Weight72 KG
Patient RaceWhite
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