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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 Problem Migration or Expulsion of Device (1395)
Patient Problems Pain (1994); Tissue Damage (2104)
Event Date 05/01/2019
Event Type  Malfunction  
Event Description

User reported that she was on her third cycle using her lena cup and she had been loving her experience so far. On this particular day she sat down on the floor to play with her daughter and as she leaned back she felt a sudden stabbing pain. She tried to remove her cup, but it felt funny - almost as though the stem was coming through a "different hole". She went to the er where the doctor told her it looked like she had developed an abnormality due to her stitches not healing up correctly post-childbirth. (while she did not have an episiotomy, she did have some tearing that required stitches. ) the er doctor pushed the cup back up a little, then removed it normally. At this time, amber felt immediate relief. The next day, she did experience some soreness. Approximately two days after the er visit, amber went to see her ob/gyn and the doctor was not able to notice any new hole or additional tearing. Both the ob/gyn and the er doctor suspect that the stem of amber's lena cup somehow found its way into this abnormality and made the tearing worse. Amber also learned that having a tear that does not heal perfectly is not uncommon.

 
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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 Key8741790
MDR Text Key149802704
Report Number3011660924-2019-00007
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 06/27/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/27/2019
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 Received06/10/2019
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 Reuse

Patient TREATMENT DATA
Date Received: 06/27/2019 Patient Sequence Number: 1
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