MAUDE Adverse Event Report: AXENA HEALTH, INC. LEVA PELVIC HEALTH SYSTEM; PERINEOMETER

Model Number LEVA-02

Patient Problem Abdominal Cramps (2543)

Event Date 03/17/2024

Event Type  Injury  

Event Description

The reporter called regarding leva pelvic health system.The reporter mentioned having abdominal cramps while using the device.

• Brand Name: LEVA PELVIC HEALTH SYSTEM
• Type of Device: PERINEOMETER
• Manufacturer (Section D): AXENA HEALTH, INC.
• MDR Report Key: 18949527
• MDR Text Key: 338363622
• Report Number: MW5153034
• Device Sequence Number: 1
• Product Code: HIR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: LEVA-02
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 59 KG