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

Model Number	LENA-PUR-S
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2020
Type of Reportable Event	Malfunction
Event or Problem Description
User reported that she had trouble removing the cup and visited urgent care for help.She was also prescribed antibiotics.
Additional Manufacturer Narrative
Original submittal wasn't packaged after updating the report.Case was delayed in being submitted due to ssl certificate configuration errors after re-issuing certificate (ongoing since beginning of (b)(6) 2020).Fda help desk tickets (b)(4).
Event or Problem Description
User reported that she had trouble removing the cup and visited urgent care for help.She was also prescribed antibiotics.

• 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: 11181315
• Report Number: 3011660924-2021-00001
• Device Sequence Number: 17165308
• Product Code: HHE
• UDI-Device Identifier: 00850008236075
• UDI-Public: 00850008236075
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 01/15/2021

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-PUR-S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/04/2020
• Supplement Date Received by Manufacturer: 12/04/2020
• Initial Report FDA Received Date: 01/15/2021
• Supplement Report FDA Received Date: 01/15/2021
• 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