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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-PUR-L
Device Problems Entrapment of Device (1212); Fitting Problem (2183)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Malfunction  
Event Description

User reported that she used the large cup and had trouble getting it out so she had to have her doctor remove it,.

 
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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 Key8736947
MDR Text Key149802762
Report Number3011660924-2019-00006
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,OTHER
Reporter Occupation
Type of Report Initial
Report Date 06/25/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/26/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberLENA-PUR-L
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/13/2019
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: 06/26/2019 Patient Sequence Number: 1
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