Description of Event or Problem · 1
THIS COMPLAINT RELATES TO THE IMPROPER MARKETING AND INADEQUATE LABELING OF AN UNLICENSED MEDICAL DEVICE BY MEDICREATIONS OF (B)(4). MEDICREATIONS CLAIMS TO BE AN AMERICAN MANUFACTURER; YET, ALL OF ITS PRODUCTS ARE DESIGNED AND/OR CREATED IN (B)(4) (PLEASE SEE THEIR 510(K) PREMARKET NOTIFICATIONS K080382, K161286, K161692, K161925, AND K161926.) THE PARTICULAR DEVICE WHICH IS THE SUBJECT OF THIS COMPLAINT IS CALLED THE "MEDISLIM" DEVICE WHICH IS NOT ANY OF THE DEVICES DESCRIBED IN ANY OF THE MEDICREATIONS 510(K) NOTIFICATIONS LISTED ABOVE. THE DEVICE HAS NO MODEL NUMBER OR SERIAL NUMBER ON THE EQUIPMENT. THERE IS NO LABELING ON THE DEVICE INDICATING THE ADDRESS OF THE MANUFACTURER OR ANY PRESCRIPTION REQUIREMENTS. THE DEVICE EMPLOYS INFRARED LIGHT AT WAVELENGTHS BETWEEN 690 NM AND 1000 NM PURSUANT TO A GENERAL PRODUCT DESCRIPTION OFFERED BY MEDICREATIONS. THUS, IT APPEARS TO BE A CLASS II MEDICAL DEVICE WITHOUT ANY PROPER LABELING OR CONSUMER WARNINGS. THE PRODUCT WAS MARKETED AND SOLD IN (B)(4) TO MY CLIENT BY AN OFFICER OF MEDICREATIONS, (B)(4). MS. (B)(4) SOLICITED MY CLIENT'S BUSINESS IN (B)(6) AND REPRESENTED TO MY CLIENT THAT SHE WAS A REGISTERED NURSE OR A "LICENSED HEALTH CARE PRACTITIONER." BASED ON HER CLAIMED SKILLED MEDICAL KNOWLEDGE, SHE CONVINCED MY CLIENT THAT THE MEDICREATIONS DEVICE SOLD TO HER WAS SUITABLE TO MY CLIENT'S BUSINESS AND LEVEL OF EXPERTISE. AS LATER ASSERTED BY MEDICREATIONS' REPRESENTATIVE, (B)(4), IN CORRESPONDENCE OF JULY 23, 2019, MS. (B)(6) RECEIVED "EXTENSIVE TRAINING" FROM MS. (B)(6) ON (B)(6) 2018. YET, IN NONE OF THE COMMUNICATIONS WITH MY CLIENT DID MEDICREATIONS, NOR ITS OFFICER, DISCLOSE THAT MS. (B)(4) HAD HER NURSING LICENSE REVOKED BY THE (B)(6) BOARD OF NURSING A FEW MONTHS EARLIER. THE BOARD'S DISCIPLINARY DOCUMENTS DEMONSTRATE THAT MS. (B)(6) WAS UNLAWFULLY PRACTICING MEDICINE WITHOUT A LICENSE AND ENGAGING IN A PATTERN OF MARKETING ILLEGAL MEDICAL DEVICES IN (B)(6). (PLEASE SEE THE DISCIPLINARY RECORD ON THE STATE OF (B)(6) BOARD OF NURSING WEBSITE; COPIES AVAILABLE FROM ME.) THE DOCUMENTS CONFIRM MS. (B)(4) PLEAD GUILTY TO FELONY RECEIPT IN INTERSTATE COMMERCE OF MISBRANDED DRUGS AND DELIVERY THEREOF IN UNITED STATES DISTRICT COURT, CENTRAL DISTRICT OF (B)(6) CASE NUMBER (B)(4). AT THE TIME MEDICREATIONS' OFFICER WAS MARKETING THE MEDICAL DEVICE AND PROVIDING MEDICAL TRAINING, SHE WAS A CONVICTED FELON WITH NO LEGAL AUTHORIZATION TO ENGAGE IN SUCH ACTIVITIES. SHE AND HER COMPANY HAVE DEFRAUDED MY CLIENT AND THE PUBLIC. THE IMPROPER TRAINING AND CONSUMER WARNINGS RESULTED IN PHYSICAL INJURIES TO PERSONS WHO USED THE EQUIPMENT. MULTIPLE REQUESTS HAVE BEEN MADE OF THE MANUFACTURER TO PROVIDE PROPER DOCUMENTATION, CORRECTIONS AND/OR RELATED REMEDIES. THE MANUFACTURER DISCLAIMS ALL RESPONSIBILITY. ACCORDINGLY, MEDICREATIONS AND THEIR CRIMINALLY CONVICTED OFFICER, (B)(4) ARE A DANGER TO THE PUBLIC FOR THEIR UNLAWFUL MARKETING OF DEFECTIVE AND DANGEROUS (B)(4) EQUIPMENT. DOCUMENTS SUPPORTING ALL THESE MATTERS CAN BE PROVIDED. FDA SAFETY REPORT ID# (B)(4).