FDA Adverse Event Injury Summary report: N

INTENSITY IF COMBO (TENS/IF)

MDR report key: 6140212 · Received December 1, 2016

Report

Report Number
3012316249-2016-00007
Event Type
Injury
Date Received
December 1, 2016
Date of Event
November 8, 2016
Report Date
December 1, 2016
Manufacturer
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
Product Code
GZJ
Adverse Event
Yes
Product Problem
Yes
Report Source
Distributor report
Reporter Location
CA, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

THE SCREEN ON THE DEVICE MELTED, AND THE CUSTOMER WAS BURNED WHILE USING IT. THE USER HAS OWNED THE DEVICE FOR LESS THAN ONE MONTH. HE WAS USING 2" ROUND ELECTRODES, AND HE HESITANTLY CONFIRMED THAT THEY WERE IN A CRISS-CROSS PATTERN. HE STATES THIS WAS HIS SECOND OR THIRD USAGE OF THIS PARTICULAR SET OF ELECTRODES. HE KEEPS HIS ELECTRODES ON ALL THE TIME, AND ONLY REMOVES THEM FOR SHOWERING. THE ELECTRODES WERE PLACED 4-6" AWAY FROM ONE ANOTHER ON HIS BEHIND AND LEG. HE HAD THE DEVICE PLUGGED IN AND SET ON THE IF MODE (ALTHOUGH HE COULD NOT CONFIRM WHICH IF PROGRAM HE WAS USING). HE SET THE DEVICE TO CONTINUOUS SO IT WOULD RUN ALL NIGHT. HE WOKE UP SOMETIME IN THE EARLY MORNING, AS HE WAS FEELING PAIN. AT THIS POINT, HE NOTED THE SCREEN ON THE DEVICE HAD SOMEWHAT MELTED. HE LEFT HIS ELECTRODES ON UNTIL LATER IN THE EVENING, WHEN HE WENT TO TAKE A SHOWER. WHEN HE REMOVED THE ELECTRODES, HE REALIZED THERE WERE (BLISTERY) BURNS UNDERNEATH. THE USER'S PHYSICAL THERAPIST RECOMMENDED HE GET THIS DEVICE, BUT DID NOT PROVIDE ANY GUIDANCE ON TREATMENT SETTINGS. THE USER HAS PARALYSIS IN THE AREA HE WAS TREATING, WHICH THUS LIMITED FEELING. THE USER WAS TOLD (BY A COMPASS HEALTH BRANDS' CUSTOMER SERVICE REPRESENTATIVE) THAT, BECAUSE OF HIS LIMITED FEELING, HE WOULD MOST LIKELY TURN THE DEVICE UP HIGHER THAN SOMEONE WHO COULD FULLY FEEL THE CURRENT; HE MAY HAVE TURNED IT UP TOO HIGH. THE IF WAVEFORM IS TEN TIMES MORE POWERFUL THAN TENS, AND WOULD NOT BE RECOMMENDED FOR USE AN ENTIRE NIGHT. THE USER WAS ALSO TOLD (BY THE REP) TO REMOVE HIS ELECTRODES AFTER EACH USE - THE LONGER THEY ARE IN THE OPEN AIR, THE FASTER THEY DRY OUT AND THE USER WOULD NOT BE EXPERIENCING AN ENTIRE FLOW OF CURRENT THROUGHOUT THE ELECTRODE - THE OLDER THE ELECTRODE, THE LESS IT IS ABLE TO DISPERSE CURRENT THROUGHOUT ITSELF, THUS LIMITING CURRENT CLOSER AND CLOSER TO THE BRANCH IN THE ELECTRODE, WHICH COULD CAUSE A HOT SPOT. THE END-USER ALSO STATES THAT HE DID NOT NOTICE THAT THE PLASTIC ON THE WIRE HAD SHRUNK OR PULLED APART, AND THERE IS A 1/4" OF THE WIRE SHOWING. IT IS OTHERWISE KNOWN THAT THE USER TURNS THE DEVICE ON AND INCREASES THE INTENSITY, BUT HIS WIFE PLACES THE ELECTRODES.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
788143 INTENSITY IF COMBO (TENS/IF) TENS UNIT GZJ SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. DI4738 N/A

Patients

Seq Age Sex Outcome Treatment
1 47 YR Other