MAUDE Adverse Event Report: LELO INC INTIMINA LILY CUP COMPACT A ; CUP, MENSTRUAL

Health Effect - Clinical Code	Pain (1994)
Date of Event	02/25/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Purchased intimina lily cup menstrual period collection device.(i bought the correct fit and have used intravaginal birth control devices prior so i am familiar with use of intravaginal devices).This cup created so much suction / vacuum on the cervix that i was unable to remove on my own.I have tried valsalva maneuvers and squatting to try to get it out but ended up having a physician remove it using a speculum and ring forceps, very painful.No longer have the product the dr threw it in the biohazard.Fda safety report id# (b)(4).

• Brand Name: INTIMINA LILY CUP COMPACT A
• Common Device Name: CUP, MENSTRUAL
• Manufacturer (Section D): LELO INC
• MDR Report Key: 9818436
• Report Number: MW5093673
• Device Sequence Number: 2855842
• Product Code: HHE
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 03/08/2020

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?: Yes
• Operator of Device: No Information
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/10/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 43 YR