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

Device Problem Migration or Expulsion of Device (1395)

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

Event Type  malfunction  

Event Description

User reported that she had trouble removing the cup and visited urgent care to have it removed.As per her description she felt it had migrated too high and consequently she couldn't break the seal.

• 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: 9197961
• MDR Text Key: 190640559
• Report Number: 3011660924-2019-00015
• 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

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
• Date Manufacturer Received: 10/12/2019
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention