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

Model Number	LENA-GRN-S
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Type of Reportable Event	Malfunction
Event or Problem Description
User reported that she tried to use the cup for 2 menstrual cycles and both times, it caused her extreme pain.She visited her obgyn to see what was the cause of the problem, but her physical went well, and therefore, she believes that the cup is not a good fit for her, and she will not be using it in the future.

• Brand Name: LENA
• Common Device Name: MENSTRUAL CUP
• Manufacturer (Section D): LENA CUP LLC; 244 fifth avenue #2243; new york NY 10001
• MDR Report Key: 10806165
• Report Number: 3011660924-2020-00015
• Device Sequence Number: 2875322
• Product Code: HHE
• UDI-Device Identifier: 00850008236020
• UDI-Public: 00850008236020
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/07/2020

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-GRN-S
• Device Lot Number: NOT AVAILABLE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2020
• Initial Report FDA Received Date: 11/07/2020
• 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