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

Model Number LENA-MIXII-2

Device Problem Difficult to Remove (1528)

Patient Problems No Known Impact Or Consequence To Patient (2692); Missing Value Reason (3192)

Event Date 08/01/2020

Event Type  malfunction  

Event Description

User reported that she had trouble removing the cup and had to visit planned parenthood for assistance to have it removed.

• 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: 10469802
• MDR Text Key: 209180503
• Report Number: 3011660924-2020-00009
• Device Sequence Number: 1
• Product Code: HHE
• UDI-Device Identifier: 00850008236143
• UDI-Public: 850008236143
• 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: Other
• Type of Report: Initial
• Report Date: 08/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: LENA-MIXII-2
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/25/2020
• 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