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

Model Number	DFL0009 REV 04
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/05/2019
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: STIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER
• Manufacturer (Section D): IPULSE MEDICAL
• MDR Report Key: 10137796
• Report Number: MW5094911
• Device Sequence Number: 15829164
• Product Code: NUH
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date (Section B): 06/06/2020

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
• Device Model Number: DFL0009 REV 04
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 16 YR