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

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).

• Brand Name: LIVIA
• Type of Device: STIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER
• Manufacturer (Section D): IPULSE MEDICAL
• MDR Report Key: 10137796
• MDR Text Key: 194870287
• Report Number: MW5094911
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 06/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: DFL0009 REV 04
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 16 YR