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

Model Number	CLR S
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Type of Reportable Event	Malfunction
Event or Problem Description
User reported that she was diagnosed with bacterial vaginosis while using the cup.She visited her physician who prescribed antibiotics.

• Brand Name: LENA
• Common Device Name: MENSTRUAL CUP
• Manufacturer (Section D): LENA CUP LLC; 244 fifth avenue #2243; new york, ny
• MDR Report Key: 10084739
• Report Number: 3011660924-2020-00022
• Device Sequence Number: 13647361
• Product Code: HHE
• UDI-Device Identifier: 00850008236082
• UDI-Public: 00850008236082
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/23/2020

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: CLR S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/03/2020
• Initial Report FDA Received Date: 05/23/2020
• 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