MAUDE Adverse Event Report: LENA CUP LLC LENA MENSTRUAL CUP

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Discomfort (2330); Fungal Infection (2419)

Event Type  malfunction  

Event Description

User reported that she had recurrent, prolonged yeast infections after using the cup, the last one taking a total of 3 months to resolve with doctor visits every other week and trailing a total of 6 different medications to get rid of the infection, not to mention the discomfort.

• Brand Name: LENA MENSTRUAL CUP
• 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: 8664606
• MDR Text Key: 149802725
• Report Number: 3011660924-2019-00004
• Device Sequence Number: 1
• Product Code: HHE
• 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,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 05/30/2019
• Initial Date FDA Received: 06/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention