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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LENA CUP LLC LENA CUP MENSTRUAL CUP

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LENA CUP LLC LENA CUP MENSTRUAL CUP Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Micturition Urgency (1871); Rash (2033)
Event Type  Malfunction  
Event Description

User reported that she experienced severe itching (determined to be a contact rash) for +/-5 days after each menstrual cycle ends. Physician prescribed topical steroid cream which was effective. However since february the user has been experiencing bladder urgency (no frequency) which her physician is not sure if related to the lena product as there is no infection or other causes for the urgency.

 
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Brand NameLENA CUP
Type of DeviceMENSTRUAL 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 Key8858399
MDR Text Key179119168
Report Number3011660924-2019-00010
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,DISTRIBUTOR
Reporter Occupation
Type of Report Initial
Report Date 08/04/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/04/2019
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
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/30/2019
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 08/04/2019 Patient Sequence Number: 1
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