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U.S. Department of Health and Human Services

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

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IPULSE MEDICAL LIVIA TENS UNIT STIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER Back to Search Results
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).
 
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Brand NameLIVIA TENS UNIT
Type of DeviceSTIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER
Manufacturer (Section D)
IPULSE MEDICAL
MDR Report Key10250481
MDR Text Key198395585
Report NumberMW5095446
Device Sequence Number1
Product Code NUH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received07/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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