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Patient 1
BURN WITH REDNESS AND DETACHING SKIN [THERMAL BURN], BURN WITH REDNESS AND DETACHING SKIN [SKIN EXFOLIATION]. CASE NARRATIVE: THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER OR OTHER NON HEALTHCARE PROFESSIONAL VIA MEDICAL INFORMATION TEAM. A FEMALE PATIENT OF AN UNSPECIFIED AGE STARTED TO USE THERMACARE HEATWRAP (THERMACARE MENSTRUAL) FROM AN UNSPECIFIED DATE FOR AN UNSPECIFIED INDICATION. THE PATIENT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNSPECIFIED DATE, THE PATIENT REPORTED DURING THE LAST USAGE OF THE HEATWRAP SHE OBSERVED AN ISSUE. SHE FELT A STRONG, SELECTIVE BURNING SENSATION WHILE USING THE HEATWRAP. WHEN SHE CHECKED IT, SHE FOUND SHE HAD AN APPROXIMATELY 2 CENTIMETER BURN AT THIS POINT. THIS BURN WAS SHOWN BY REDDENING AND A GRADUAL DETACHMENT OF SKIN. THE PATIENT ENDED THE APPLICATION IMMEDIATELY, OF COURSE. ACTION TAKEN WITH THE SUSPECT PRODUCT WAS PERMANENTLY WITHDRAWN ON AN UNSPECIFIED DATE. CLINICAL OUTCOME OF THE EVENTS WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE PROVIDED AS IT BECOMES AVAILABLE. COMPANY CLINICAL EVALUATION COMMENT: BASED ON THE INFORMATION PROVIDED, THE EVENTS THERMAL BURN AND SKIN EXFOLIATION AS DESCRIBED ARE CONSIDERED SERIOUS BODILY INJURY POTENTIALLY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT OF BODY STRUCTURE. THE EVENTS ARE MEDICALLY ASSESSED AS ASSOCIATED WITH THE USE OF THE DEVICE. COMMENT: BASED ON THE INFORMATION PROVIDED, THE EVENTS THERMAL BURN AND SKIN EXFOLIATION AS DESCRIBED ARE CONSIDERED SERIOUS BODILY INJURY POTENTIALLY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT OF BODY STRUCTURE. THE EVENTS ARE MEDICALLY ASSESSED AS ASSOCIATED WITH THE USE OF THE DEVICE.