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

Model Number	LENA-PUR-S
Medical Device Problem Codes	Difficult to Remove (1528); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	08/11/2020
Type of Reportable Event	Malfunction
Event or Problem Description
User reported that her iud was dislodged while removing the cup.She described having a high cervix and that the cup had moved up as she was sleeping.It was becoming difficult to remove because it was high up and although she was breaking the seal, she could not get a grip on the cup.After she was able to, she pulled the cup out and found the iud inside.She has contacted her gyn and has scheduled an appointment to discuss how this may have occurred and to have the iud replaced.

• Brand Name: LENA
• Common Device Name: MENSTRUAL CUP
• Manufacturer (Section D): LENA CUP LLC; 244 fifth avenue #2243; new york, ny
• MDR Report Key: 10443234
• Report Number: 3011660924-2020-00007
• Device Sequence Number: 4043891
• Product Code: HHE
• UDI-Device Identifier: 00850008236075
• UDI-Public: 00850008236075
• 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-PUR-S
• Device Lot Number: 165229
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/11/2020
• 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