TENDLIFE

Description of Event or Problem

TENDLITE ADVERSE REACTION DESCRIPTION: SHINGLES. I HAVE A DIAGNOSED INFLAMED SPINAL DISK BETWEEN L3 AND L4 ON THE RIGHT. ON (B)(6) 2020, I HAD AN EPIDURAL STEROID INJECTION TO RELIEVE PRESSURE ON THE NERVE COMING THAT COMES OUT THERE, DUE TO PROLONGED PAIN FROM MY RIGHT HIP DOWN TO MY ANKLE. THIS ABNORMALITY WAS DUE TO A SPORTS INJURY IN (B)(6) 2019. ON APPROXIMATELY (B)(6) 2021 (NOT WRITTEN DOWN, BUT WAS AROUND THAT TIME), I USED TENDLITE TO ADMINISTER 3 1-MINUTE TREATMENTS TO MY SPINE AT A LOCATION THAT WAS AS BEST AS I COULD GUESS WHERE L3 AND L4 WOULD BE. (IT'S RED LIGHT THERAPY, YOU SHINE A DEVICE THAT LOOKS LIKE A SMALL FLASHLIGHT. YOU PLACE IT ON THE SURFACE OF YOUR SKIN AT THE AFFECTED AREA.) I LOOKED ONLINE FIRST FOR INFORMATION STATING WHETHER THIS WOULD BE A BAD IDEA AND DIDN'T FIND ANYTHING. I WOULD HAVE PREFERRED TO HAVE A REPEAT STEROID INJECTION AT THE END OF (B)(6) 2020, BUT IT HAS BEEN DELAYED TO SOME TIME AFTER (B)(6) 2021 DUE TO A CHANGE IN INSURANCE AND WAIT TIME TO GET ESTABLISHED WITH AN IN-NETWORK PHYSICIAN. ON (B)(6) 2020, SHINGLES RASHES BEGAN APPEARING ON THE RIGHT SIDE ON MY BACK AND MY HIP. THOUGH THE SHINGLES VIRUS HAD TO BE IN MY SYSTEM FOR IT TO APPEAR, AND I WOULDN'T HAVE USED THE TENDLITE AT THAT LOCATION IF I DIDN'T HAVE A SPINAL INJURY (WHICH LIKELY CONTRIBUTED TO THE SHINGLES, TOO), IT DOES SEEM MOST LIKELY THAT THE TENDLITE AGITATED THE SHINGLES VIRUS AND STARTED AN EPISODE. THIS IS THE FIRST CASE OF SHINGLES I HAVE HAD. I ALSO USED THE TENDLITE TO ADMINISTER TREATMENT TO MY LEFT HIP NEAR WHERE THE IT BAND IS ATTACHED (WHICH I'VE ALREADY COMPLETED IN OFFICE PHYSICAL THERAPY FOR, AND CONTINUED EXERCISES AT HOME). IT RELIEVED THE PAIN AND DID NOT CAUSE ANY SIDE EFFECTS. ON (B)(6) 2021, SHINGLES WAS DIAGNOSED AT A DOCTOR'S VISIT. DISCUSSED THAT THE INJURY AND TENDLITE MAY HAVE BEEN THE OPPORTUNITIES THAT CAUSED THE SHINGLES VIRUS TO ACTIVATE. FDA SAFETY REPORT ID#: (B)(4).