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

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

Patient Problems Bacterial Infection (1735); Fungal Infection (2419)

Event Date 07/01/2019

Event Type  malfunction  

Event Description

User reported that she had a checkup with her gynecologist and told her that she's recently been using a menstrual cup.Her gyn immediately warned against cups and tampons as the blood has to "leave the body immediately".She's been having a bacterial/fungal infection for a while and was told that the cup is a probable cause and that she should discontinue using it in order to stop getting infections.

• 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: 8812761
• MDR Text Key: 152049977
• Report Number: 3011660924-2019-00008
• 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: 07/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2019
• 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: 07/02/2019
• 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): Required Intervention