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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 Difficult to Remove (1528)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/19/2019
Event Type  Malfunction  
Event Description

User reported that she had trouble removing the cup. She visited urgent care to have the cup removed and the physician advised that given the way it was lodged, from her angle, she wouldn't have been able to remove it.

 
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Brand NameLENA
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 Key8923893
MDR Text Key190640373
Report Number3011660924-2019-00012
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 08/23/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/22/2019
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 Received08/18/2019
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

Patient TREATMENT DATA
Date Received: 08/22/2019 Patient Sequence Number: 1
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