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

Model Number	LENA-ORG-S
Health Effect - Clinical Code	Neuralgia (4413)
Date of Event	02/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Pain with urination and pain in the upper backs of thighs.

• Brand Name: LENA CUP
• Common Device Name: MENSTRUAL CUP
• Manufacturer (Section D): LENA CUP; 3540 highway 52; frederick CO 80516
• Manufacturer (Section G): LENA CUP; 3540 highway 52; frederick CO 80516
• Manufacturer Contact: lachlan thom ; 3540 highway 52; frederick, CO 80516
• MDR Report Key: 13516932
• Report Number: 3011390138-2022-00001
• Device Sequence Number: 4385230
• Product Code: HHE
• UDI-Device Identifier: 00850008236136
• UDI-Public: 00850008236136
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/11/2022

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
• Device Model Number: LENA-ORG-S
• Device Catalogue Number: LENA-ORG-S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2022
• Initial Report FDA Received Date: 02/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female