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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 Difficult to Remove (1528)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/05/2019
Event Type  Malfunction  
Event Description

User purchased both size cups and originally used the small size which she stated she had difficulty in removing originally. She then tried the large cup for better grip but wasn't able to remove this because it had moved too high up and couldn't be reached. She "seeked" medical assistance to have the cup removed.

 
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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 Key8904248
MDR Text Key190640221
Report Number3011660924-2019-00011
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 08/17/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/17/2019
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
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: 08/17/2019 Patient Sequence Number: 1
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