FDA Adverse Event Malfunction Summary report: N

LIVIA

MDR report key: 10137796 · Received June 9, 2020

Report

Report Number
MW5094911
Event Type
Malfunction
Date Received
June 9, 2020
Date of Event
December 5, 2019
Report Date
June 6, 2020
Manufacturer
IPULSE MEDICAL
Product Code
NUH
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
OR, US
Reporter Occupation
PATIENT FAMILY MEMBER OR FRIEND

Narratives

Description of Event or Problem · 1

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).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
595672 LIVIA STIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER NUH IPULSE MEDICAL DFL0009 REV 04

Patients

Seq Age Sex Outcome Treatment
1 16 YR