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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LENA CUP LLC LENA MENSTRUAL CUP

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LENA CUP LLC LENA MENSTRUAL CUP Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Discomfort (2330); Fungal Infection (2419)
Event Type  malfunction  
Event Description
User reported that she had recurrent, prolonged yeast infections after using the cup, the last one taking a total of 3 months to resolve with doctor visits every other week and trailing a total of 6 different medications to get rid of the infection, not to mention the discomfort.
 
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Brand Name
LENA MENSTRUAL CUP
Type of Device
MENSTRUAL CUP
Manufacturer (Section D)
LENA CUP LLC
244 fifth avenue #2243
new york NY 10001
Manufacturer (Section G)
IRP MEDICAL
1035 calle amanecer
san clemente CA 92673
Manufacturer Contact
rey obnamia
1035 calle amanecer
san clemente, CA 92673
MDR Report Key8664606
MDR Text Key149802725
Report Number3011660924-2019-00004
Device Sequence Number1
Product Code HHE
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Other
Type of Report Initial
Report Date 06/03/2019
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 Operator Lay User/Patient
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 05/30/2019
Initial Date FDA Received06/03/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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