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

Model Number	LENA-MIXII-2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Menstrual Irregularities (1959); Intermenstrual Bleeding (2665)
Type of Reportable Event	Serious Injury
Event or Problem Description
User reported that she experienced two episodes of spotting well after using the cup.She is working with her physician to possibly determine the cause.

• Brand Name: LENA CUP
• Common Device Name: MENSTRUAL CUP
• Manufacturer (Section D): LENA CUP LLC; 244 fifth avenue #2243; new york, ny
• MDR Report Key: 10345871
• Report Number: 3011660924-2020-00006
• Device Sequence Number: 811251
• Product Code: HHE
• UDI-Device Identifier: 00850008236143
• UDI-Public: 00850008236143
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: LENA-MIXII-2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/13/2020
• Initial Report FDA Received Date: 07/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other