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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypersensitivity/Allergic reaction (1907); Skin Irritation (2076); Fungal Infection (2419)
Event Type  Malfunction  
Event Description

User reported that she had developed a yeast infection previously when using the cup but had not been tested to confirm this and had taken medication independently which seemed to clear up the problem. Since then she has now reused the cup and experienced soreness and skin irritation. After visiting the physician she was tested and didn't have a yeast infection but was told that it appears she may be allergic to the material or a substance of the cup.

 
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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 Key8962112
MDR Text Key190639755
Report Number3011660924-2019-00013
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 09/04/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/04/2019
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 Received08/31/2019
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: 09/04/2019 Patient Sequence Number: 1
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