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

Device Problem Difficult to Remove (1528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/14/2019

Event Type  Malfunction  

Event Description

User reported that she had trouble removing the cup. She visited urgent care to have the cup removed again as this was the 2nd time in the last couple of months. The user though has once again expressed interest in using the cup but is now afraid and is seeking advice.

• 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: 9198538
• MDR Text Key: 190639621
• Report Number: 3011660924-2019-00016
• 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

• Type of Report: Initial
• Report Date: 10/15/2019

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 10/16/2019
• 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

Is The Reporter A Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/15/2019
• Was Device Evaluated By Manufacturer?: No
• Is The Device Single Use?: No Answer Provided
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient TREATMENT DATA

Date Received: 10/16/2019 Patient Sequence Number: 1