• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

IPULSE MEDICAL LIVIA STIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER Back to Search Results
Model Number DFL0009 REV 04
Device Problem Defective Component (2292)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/05/2019
Event Type  malfunction  
Event Description
My daughter ordered and started using the livia product (company ipulse medical ltd) in late (b)(6) 2019. It stopped working in early (b)(6), about 6 weeks later. She contacted the company for replacement as it was well within the 3 month warranty. Livia was very non-responsive. They have no phone contact or customer support, only email. Eventually they emailed us authorization and instructions to return the device for replacement. We were required to pay return postage but they said they would replace it. When we returned it to the address they provided, the return was denied by the company and sent back to us. We contacted them many times again. Eventually they were very apologetic and said they had a new system in place and we were to ship back to them cod and they would reimburse us postage upon receipt. I was very reluctant to do this as it was very expensive ((b)(6) shipping and cod fee). Once again they refused the shipment and returned it to us. I sent them an email in early (b)(6) and told them if we didn't receive our replacement device by the end of (b)(6) we would file a complaint with the fda for the maude database. Additionally, we tried posting a review on their site but they have to approve all reviews and only post the positive ones. We found online forums where many have posted this company is a scam. In my research their ceo, (b)(6) is based in (b)(6). The web address for the company is in (b)(6). I am beginning to doubt they have any actual presence in the united states, other than a shipping warehouse in (b)(6), if that. I tried contacting the customer support manager via (b)(6), but no reply. The web page is https://mylivia. Com/za/contact-us-2/. Fda safety report id# (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLIVIA
Type of DeviceSTIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER
Manufacturer (Section D)
IPULSE MEDICAL
MDR Report Key10137796
MDR Text Key194870287
Report NumberMW5094911
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 Family Member or Friend
Type of Report Initial
Report Date 06/06/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberDFL0009 REV 04
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? No
Type of Device Usage

-
-