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

Model Number	LENA-GRN-S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2020
Type of Reportable Event	Malfunction
Event or Problem Description
User reported that she had trouble removing the cup and visited a doctor for help.The physician prescribed a short course of antibiotics as a precaution because the cup hadn't been removed for over 2 days.The user reported feeling fine after the incident.

• Brand Name: LENA CUP
• Common Device Name: MENSTRUAL CUP
• Manufacturer (Section D): LENA CUP LLC; 244 fifth avenue #2243; new york NY 10001
• MDR Report Key: 10731878
• Report Number: 3011660924-2020-00013
• Device Sequence Number: 3450614
• Product Code: HHE
• UDI-Device Identifier: 00850008236020
• UDI-Public: 00850008236020
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 10/24/2020

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: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2020
• Initial Report FDA Received Date: 10/24/2020
• 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