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

Device Problem Shipping Damage or Problem (1570)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event 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
• Type of Device: STIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER
• Manufacturer (Section D): IPULSE MEDICAL
• MDR Report Key: 10250481
• MDR Text Key: 198395585
• Report Number: MW5095446
• Device Sequence Number: 1
• Product Code: NUH
• 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: 07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Weight: 93