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

Model Number	LENA-PUR-S
Health Effect - Clinical Code	Skin Tears (2516)
Date of Event	07/30/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
User described extreme pain and punctured skin.User sought medical treatment.

• 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; 350 highway 52; suite h12; frederick CO 80516
• Manufacturer Contact: lachlan thom ; 3540 highway 52; suite h12; frederick, CO 80516
• MDR Report Key: 15221969
• Report Number: 3011390138-2022-00004
• Device Sequence Number: 14595505
• Product Code: HHE
• UDI-Device Identifier: 00850008236075
• UDI-Public: 00850008236075
• Combination Product (Y/N): N
• 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): 08/04/2022

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-PUR-S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2022
• Initial Report FDA Received Date: 08/12/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown