MAUDE Adverse Event Report: IPULSE MEDICAL LIVIA TENS UNIT; STIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER

Medical Device Problem Code	Shipping Damage or Problem (1570)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
Livia is a period pain reduction unit.This tens unit does work but the company is scamming thousands of women.The site contains no address or phone number.They take your money and send no product.There is a subscription service, they are taking out the (b)(6) a month consistently but not providing any of the tools needed to keep using the product.I have emailed dozens of times and they simply will not respond.(b)(4).

• Brand Name: LIVIA TENS UNIT
• Common Device Name: STIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER
• Manufacturer (Section D): IPULSE MEDICAL
• MDR Report Key: 10250481
• Report Number: MW5095446
• Device Sequence Number: 3475719
• Product Code: NUH
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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): 07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/08/2020
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Weight: 93