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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Micturition Urgency (1871); Rash (2033)

Event Type  malfunction  

Event Description

User reported that she experienced severe itching (determined to be a contact rash) for +/-5 days after each menstrual cycle ends.Physician prescribed topical steroid cream which was effective.However since february the user has been experiencing bladder urgency (no frequency) which her physician is not sure if related to the lena product as there is no infection or other causes for the urgency.

• Brand Name: LENA 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: 8858399
• MDR Text Key: 179119168
• Report Number: 3011660924-2019-00010
• 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,distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2019
• 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
• Date Manufacturer Received: 07/30/2019
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other