CLINIC CALLED TODAY STATING THEY PURCHASED 3 INTENSITY EX4'S FROM THE ABOVE DISTRIBUTOR. THEY STATE THEY HAVE HAD MULTIPLE PATIENTS BURNED ON ALL THREE OF THEIR DEVICES. SHE IS USING LATEX FREE ELECTRODES FROM TOTAL MEDICAL RESOURCES. SHE USED A LOWER BRAND FROM THEM BUT THEN CHANGED TO THEIR PLATINUM VERSION. BURNS OCCURRED WITH BOTH. SHE IS USING THE ELECTRODES IN A CRISS-CROSS PATTERN. (THEY USE THE ELECTRODES BETWEEN 6" ON THE NECK AND/OR LOW BACK. IN EACH CASE ONLY ONE ELECTRODE BURNED THE PATIENT.) OUR PRODUCT MANAGER SAID THESE ELECTRODES ARE NOT "CLINICAL GRADE" ELECTRODES. WHEN QUESTIONED ABOUT THE INTENSITY LEVELS THEY WERE USING I WAS TOLD THEY DO GO BY PATIENT FEEL. NONE OF THEIR PATIENTS FELT THEIR INTENSITY WAS TOO HIGH OR EVEN REALIZED THEY HAD A BURN UNTIL AN HOUR OR TWO LATER. THE WIDE VARIATION OF INTENSITY THEY HAVE USED GOES FROM 8-35, RARELY DO THEY GO ABOVE 40. A DAY AFTER THE INITIAL REPORT SHE ADMITS THEY DO NOT KNOW WHICH DEVICE(S) BURNED PATIENTS AS THEY DID NOT KEEP TRACK. THE CUSTOMER STATES THE PATIENT RECEIVED A 3RD DEGREE BURN.
D
Patient 1
THERAPIST STATES SHE ALWAYS USES THE PRESET FOR ACUTE PAIN/4 ELECTRODES. FIRST OUR PRODUCT MANAGER SAID THESE WERE NOT CLINICAL GRADE ELECTRODES BECAUSE WE SELL THE ELECTRODES, THE BRAND ELECTRODES THEY CLAIM TO BE USING. LATER SHE RECANTED AND SAID THEY ALSO PURCHASE ELECTRODES FROM OTHER MANUFACTURERS AND NOW SHE ISN'T SURE. A DAY AFTER THE INITIAL REPORT THE END-USER ADMITS THEY DO NOT KNOW WHICH DEVICE(S) BURNED PATIENTS AS THEY DID NOT KEEP TRACK. THE SERIAL NUMBERS FOR THESE DEVICES ARE (B)(4).
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Patient 1
DEVICES SZ16070009000113 AND SZ16090009000191 WERE RETURNED AND INSPECTED ON 04/03/2018. THE WARRANTY SEALS WERE BROKEN ON BOTH DEVICES, NO COSMETIC DEFECTS WERE FOUND, AND BOTH DEVICES TESTED FOR PRODUCT PERFORMANCE AND DETERMINED TO FALL WITHIN THE MANUFACTURER'S SPECIFICATIONS AS DEFINED IN THE PRODUCT USER MANUAL.