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

Model Number	LENA-MIXII-2
Medical Device Problem Codes	Difficult to Fold, Unfold or Collapse (1254); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Urinary Tract Infection (2120); Dysuria (2684)
Type of Reportable Event	Malfunction
Event or Problem Description
User reported that since using the cups from (b)(6) 2019 and onwards that she has noticed having issues with constant uti's after every period that she used them.She has had to visit her physician for antibiotics.She has also had issues with the cup insertion and not opening completely once inserted, as well as having a lot of pressure on her bladder, making it feel like she can't empty her bladder completely when the cup is inserted.

• Brand Name: LENA
• Common Device Name: MENSTRUAL CUP
• Manufacturer (Section D): LENA CUP LLC; 244 fifth avenue #2243; new york, ny
• MDR Report Key: 10445879
• Report Number: 3011660924-2020-00008
• Device Sequence Number: 4043892
• Product Code: HHE
• UDI-Device Identifier: 00850008236143
• UDI-Public: 850008236143
• 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): 08/24/2020

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-MIXII-2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/22/2020
• Initial Report FDA Received Date: 08/24/2020
• 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