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

Model Number LENA-PUR-S

Device Problems Difficult to Remove (1528); Device Dislodged or Dislocated (2923)

Patient Problem Not Applicable (3189)

Event Date 08/11/2020

Event Type  malfunction  

Event 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
• Type of Device: MENSTRUAL CUP
• Manufacturer (Section D): LENA CUP LLC; 244 fifth avenue #2243; new york, ny
• Manufacturer (Section G): IRP MEDICAL; 1035 calle amanecer; san clemente, ca
• Manufacturer Contact: rey obnamia ; 1035 calle amanecer; san clemente, ca
• MDR Report Key: 10443234
• MDR Text Key: 204254308
• Report Number: 3011660924-2020-00007
• Device Sequence Number: 1
• Product Code: HHE
• UDI-Device Identifier: 00850008236075
• UDI-Public: 00850008236075
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: LENA-PUR-S
• Device Lot Number: 165229
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other