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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
Model Number LENA-MIXII-2
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Menstrual Irregularities (1959); Intermenstrual Bleeding (2665)
Event Type  Injury  
Event Description

User reported that she experienced two episodes of spotting well after using the cup. She is working with her physician to possibly determine the cause.

 
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Brand NameLENA CUP
Type of DeviceMENSTRUAL CUP
Manufacturer (Section D)
LENA CUP LLC
244 fifth avenue #2243
new york, ny
Manufacturer (Section G)
IRP MEDICAL
1035 calle amanecer
san clemente, ca
Manufacturer Contact
rey obnamia
1035 calle amanecer
san clemente, ca 
MDR Report Key10345871
MDR Text Key202753853
Report Number3011660924-2020-00006
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
Reporter Occupation
Type of Report Initial
Report Date 07/30/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/30/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberLENA-MIXII-2
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/13/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 07/30/2020 Patient Sequence Number: 1
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