Description of Event or Problem · 0
DATE OR INTERACTION: (B)(6) 2022. PATIENT REPORTS HYPERPIGMENTATION, DISCOLORATION, SWELLING AND ERYTHEMA WITH USE OF DEVICE AND PRODUCTS LABELED +VOUPRE PURCHASED IN LOCATION IN (B)(6). PACKAGING INCLUDES "FDA CLEARED" LABELING AS WELL AS "PATENT PENDING". PACKAGING AND PRODUCTS DO NOT HAVE SEALS, SHRINK WRAP OR UL LABELING ON THE DEVICES OR PRODUCTS. PATIENT REPORTS THAT THE MEDICAL PROVIDER AND REPRESENTATIVES MISCHARACTERIZED THE PRODUCTS AS HAVING PHYSICAL AND COSMETIC HEALTH BENEFITS. PATIENT REPORTS SHE WAS NOT ADVISED OF ACTIVE INGREDIENTS OR WAS EVALUATED FOR MEDICAL OR ALLERGIC POTENTIAL OF TREATMENT. PATIENT REPORTS THAT SHE HAS BEEN EVALUATED FOR INFECTIOUS CONJUNCTIVITIS AT (B)(6) DATE OF SERVICE (B)(6) 2022. PRESCRIBED ANTIBIOTICS AND DISCHARGED OUTPATIENT. CONCERN FOR INFECTION RISK, MANUFACTURING DEFECT AND MISREPRESENTATION TO CONSUMERS FOR FALSE ADVERTISING AND MEDICAL DEVICE REPRESENTATION. REPRESENTATIVE FOR COMPANY, +VOUPRE "(B)(4)", IDENTIFIED HIMSELF TO PATIENT AS REPRESENTATIVE OF COMPANY AND DR. (B)(6). CONCERN FOR EXPOSURE TO AT HOME UVA UVB AND INFECTION EXPOSURE. CONCERN FOR UNLABELED PRODUCTS QUALITY CONTROL AND MANUFACTURING. PRODUCTS ARE NOT SEALED, NO SAFETY WRAPPING ON DEVICES. TREATMENT DATES: (B)(6) 2022 OTC, COMPOUNDED; EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED; EVENT REAPPEARED AFTER REINTRODUCTION. FDA SAFETY REPORT ID #:(B)(4).