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

Model Number GRN S

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Urinary Tract Infection (2120)

Event Type  malfunction  

Event Description

User reported that she has experienced urinary tract infections with the cup use.She discussed with her physician who advised her that with the cup in place she is not able to empty her bladder and thus resulting in the infections.The previous incident she had reported was prior to the lena qms in 2019 and therefore it hadn't been reported.At the time she had advised that she was put on antibiotics for the infection.

• Brand Name: LENA
• Type of Device: MENSTRUAL CUP
• Manufacturer (Section D): LENA CUP LLC; 244 fifth avenue #2243; new york, ny
• Manufacturer (Section G): IRP MEDICAL; 1035 calle amanecer; san clemente, ca
• Manufacturer Contact: rey obnamia ; 1035 calle amanecer; san clemente, ca
• MDR Report Key: 10084738
• MDR Text Key: 198739148
• Report Number: 3011660924-2020-00021
• Device Sequence Number: 1
• Product Code: HHE
• UDI-Device Identifier: 00850008236020
• UDI-Public: 00850008236020
• 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: 05/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: GRN S
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/27/2020
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other