Description of Event or Problem · 0
ON 27-MAR-2026, THIS REPORT WAS RECEIVED REGARDING A 43-YEAR-OLD FEMALE CONSUMER IN THE US IN ASSOCIATION WITH A KT HEALTH BACK PAIN RELIEF PATCHES WITH COOLING MENTHOL. ON (B)(6) -2026, THE CONSUMER APPLIED A KT HEALTH BACK PAIN RELIEF PATCH WITH COOLING MENTHOL TO HER BACK FOR AN UNSPECIFIED INDICATION. THE CONSUMER REMOVED THE PATCH AFTER APPROXIMATELY 24 HOURS. WHEN SHE REMOVED IT, SHE HAD DIME SIZED BLISTERS WHICH DISCHARGE COMING OUT OF THEM AT THE APPLICANT SITE. THE APPLICATION AREA WAS RED, AND THE SKIN WAS IRRITATED WHERE THE PATCH WAS LIFTED. SHE WAS FEVERISH FOR A DAY AND WAS LETHARGIC. SHE KEPT THE AREA CLEAN. SHE DID NOT SEEK MEDICAL ATTENTION DUE TO NOT HAVING HEALTH INSURANCE. THE CONSUMER DECLINED TO PROVIDE FURTHER INFORMATION.