Description of Event or Problem · 1
THIS SPONTANEOUS REPORT WAS RECEIVED FROM A (B)(6) Y/O FEMALE PT REPORTING ON SELF FROM THE UNITED STATES (B)(6). THE PT'S WEIGHT WAS (B)(6). THE PT'S MEDICAL HISTORY AND CONCURRENT CONDITIONS INCLUDED BLOOD PRESSURE PROBLEM, HEART DISORDER (ARTERIES PROBLEMS) AND THYROID DISORDER. THE PT DID NOT HAVE ANY ALLERGIES. ON (B)(6) 2018, FIRST TIME, THE PT STARTED USING NEUTROGENA MICRODERMABRASION SYSTEM (TOPICAL, BATCH 1318RDA3) JUST ONE PAD, JUST THAT ONE TIME AS CLEANSE. ON (B)(6) 2018, THE PT REPORTED THAT PRODUCT BURNT HER FACE. HER FACE WAS BLOOD RED, ITCHY AND WAS PEELING DUE TO WHICH SHE HAD TO MISS HER WORK. SHE DID NOT EXPERIENCED SIMILAR REACTION BEFORE. ON AN UNSPECIFIED DATE IN (B)(6) 2018, SHE VISITED TO DR WHO GAVE ONE SHOT OF A STEROID SHOT AND A BENADRYL SHOT (INJECTION). ACTION TAKEN WITH NEUTROGENA MICRODERMABRASION SYSTEM WAS NOT APPLICABLE. THE OUTCOME WAS NOT RESOLVED FOR EVENT ITCHY FACE, RED FACE, PEELING OF SKIN AND FOR BURNT FACE. THIS REPORT DID NOT MEET PRODUCT QUALITY COMPLAINT CRITERIA AND DOES NOT INVOLVE A PRODUCT QUALITY COMPLAINT. THIS REPORT WAS SERIOUS (MEDICALLY SIGNIFICANT). APPLICATION SITES - BURN, PRURITUS. DOSE: JUST ONE PAD JUST THAT ONE TIME, TOPICAL. THERAPY DATES: (B)(6) 2018 - (B)(6) 2018. DIAGNOSIS FOR USE: REMOVAL OF INERT MATTER FROM SKIN OR SUBCUTANEOUS TISSUE. MFR REPORT NUMBER: (B)(4). DATE RECEIVED BY MFR: 11/12/2018.