MAUDE Adverse Event Report: LENA CUP LLC LENA; MENSTRUAL CUP

Model Number RED S

Device Problem Difficult to Remove (1528)

Patient Problem Abnormal Vaginal Discharge (2123)

Event Type  malfunction  

Event Description

Customer reported that after using the cup for 2.5 days it appeared to be lodged and she was not able to remove it.Approximately 48 hours later she started to feel lethargic and noticed spotting again.She once again tried to remove the cup and was able to this time.She then experienced discharge and smell for almost 2.5 weeks that required treatment to resolve.

• Brand Name: LENA
• Type of Device: MENSTRUAL 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 Key: 10826162
• MDR Text Key: 241124742
• Report Number: 3011660924-2020-00017
• Device Sequence Number: 1
• Product Code: HHE
• UDI-Device Identifier: 00850008236006
• UDI-Public: 00850008236006
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: RED S
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/06/2020
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other