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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THE BLOOMI INC. BLOOMI AROUSAL OIL; LUBRICANT, PATIENT
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THE BLOOMI INC. BLOOMI AROUSAL OIL; LUBRICANT, PATIENT Back to Search Results
Patient Problems Rash (2033); Burning Sensation (2146); Discomfort (2330)
Event Type  Injury  
Event Description
I am a former employee of the company and believe this company has used various claims of products being "organic, natural, clean, non-toxic", etc.However the products are actually not developed in a way that supports these claims.The company was claiming it was usda or fda certified before it was actually certified (i am not sure if the company now has any certification, but it didn't when i was an employee just two months ago).If it does has certification, it may have submitted false information to the fda/usda.The company also makes several health and medical claims (such as products increasing arousal, etc.) that are not substantiated with any sort of research, surveys, labs, certifications, or clinical studies.It not only sells medical products (i.E.Lubricants) under these false claims but also other wellness products under these claims as well.The company sells these products on it's own websites as well as through major retailers ((b)(6), etc.) unfortunately, when i was an employee with the company we received dozens of complaints that the products were burning customers, causing rashes, and other serious discomforts.You can see some of these complaints via reviews of the products at (b)(6).
 
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Brand Name
BLOOMI AROUSAL OIL
Type of Device
LUBRICANT, PATIENT
Manufacturer (Section D)
THE BLOOMI INC.
5804 rainbow hill road
agoura hills CA 91301
MDR Report Key18485509
MDR Text Key332605778
Report NumberMW5150070
Device Sequence Number1
Product Code KMJ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Unknown
Type of Report Initial
Report Date 12/27/2023
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? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/09/2024
Patient Sequence Number1
Patient Outcome(s) Other;
Patient SexPrefer Not To Disclose
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