Description of Event or Problem · 1
I PURCHASED AN ERCHONIA LASER PL-5000, AT AN ERCHONIA SEMINAR IN 2006 AND NEED CLARIFICATION ON THE FDA REGULATIONS PERTAINING TO THE PURCHASE, USE AND SALE OF THIS DEVICE. MY WIFE HAS BEEN SUFFERING FROM CHRONIC NECK PAIN AND WAS IN DESPERATE NEED OF HELP. SHE DID SOME ONLINE RESEARCH AND CAME ACROSS ERCHONIA'S COLD LASER THERAPY TREATMENTS. SHE READ ABOUT THE THERAPEUTIC BENEFITS AND CALLED A COMPANY REP TO LEARN MORE. THE REP WHO HELPED MY WIFE INVITED BOTH OF US TO ATTEND A FREE SEMINAR. THE THEME OF THE SEMINAR WAS HOW TO MANAGE PAIN SYMPTOMS AND HEAL INJURIES AND REGENERATE SCAR TISSUES. MY WIFE AND I FELT SO FORTUNATE TO HAVE THIS OPPORTUNITY, THE SALES REP WAS VERY CONVINCING AND AT THE END OF THE SEMINAR HE HAD US CONVINCED TO INVEST OUR MONEY IN A PL-5000 COLD LASER. WE WEREN'T SURE HOW WE WERE GOING TO COME UP WITH THE MONEY, BUT I PROMISED MY WIFE THAT I WOULD DO WHATEVER IT TAKES SO THAT SHE CAN GET BETTER. THE SALES REP AND A SPEAKER CONDUCTING THE SEMINAR CONSIDERED THE PL-5000 TO BE THE ULTIMATE HEALING DEVICE ON THE MARKET, THERE WERE SOME PARTICIPANTS ATTENDING THE SEMINAR THAT HAD USED THE LASER AND SWORE BY IT. BY THE END OF THE SEMINAR, WE DECIDED TO INVEST THE MONEY AND ORDER THE LASER TO TAKE ADVANTAGE OF THE DISCOUNT OFFERED FOR THOSE WHO ATTENDED. WHEN WE RECEIVED THE DEVICE, IT ONLY CAME WITH A SMALL PAMPHLET TYPE MANUAL WITH DIRECTIONS ON HOW TO APPLY SETTINGS FOR A SPECIFIC INJURY/ILLNESS. MY WIFE USED THE DEVICE FAITHFULLY FOR 6 MONTHS AND WAS NOT EXPERIENCING ANY IMPROVEMENT. SHE CONTACTED THE SALES REP AND ASKED IF THERE WERE VIDEOS OR ADD'L INFO THAT COULD HELP HER UNDERSTAND HOW TO USE THE LASER AND WHICH APPLICATIONS ARE MOST SUITABLE FOR HER CONDITION, BUT THE SALES REP NEVER SENT ANYTHING. SHE WAS DISCOURAGED. NONETHELESS, SHE CONTINUED TO APPLY THE LASER TREATMENTS WITHOUT ANY RESULTS TO SHOW FOR. SHE WAS CONVINCED THAT SHE DID NOT HAVE THE PROPER TRAINING OR UNDERSTANDING OF HOW TO USE HER LASER. A YEAR LATER, SHE ATTEMPTED TO CALL ERCHONIA TO REQUEST ANY UPDATED INFO ON THE USE AND APPLICATION OF THE LASER, AND FINALLY RECEIVED A COUPLE MORE PAMPHLETS AND A DVD. UNFORTUNATELY, THE INFO SHE RECEIVED DID NOT HELP HER UNDERSTAND THE DEVICE ANY BETTER. MY WIFE HAS NOT USED THE LASER FOR THE LAST 4 YEARS, SHE REALIZED IT IS TOO COMPLEX FOR HER UNDERSTANDING AND WE DECIDED TO OFFER IT FOR SALE. THAT IS THE REASON WHY WE NEED FDA CLARIFICATION. AFTER ATTEMPTING TO POST THE PL-5000 FOR SALE ONLINE, I FOUND OUT THAT THE SALE OF THIS ITEM COULD BE REGULATED BY THE FDA AND MUST BE SOLD BY A PROPERLY LICENSED ENTITY AND PURCHASED BY ONE. I AM CONFUSED, ESPECIALLY, SINCE WE PURCHASED THE LASER WITHOUT ANY LICENSURE OR A DR'S PRESCRIPTION. I BECAME CONCERNED AND DID NOT WANT TO LIST THE ITEM FOR SALE UNTIL WE CLARIFIED THIS THROUGH ERCHONIA. ON (B)(6) 2010, I CALLED ERCHONIA AND DISCOVERED THAT THIS DEVICE COULD ONLY BE SOLD TO A LICENSED ENTITY OR BY ORDER OF A LICENSED PRACTIONER. AT THE TIME OF THE TRANSACTION, NEITHER MY WIFE NOR I WAS MADE AWARE OF THIS BY THE SALES REP WHO SOLD THE DEVICE TO US. I FEEL THAT THE SALE REP WHO SOLD ME THIS DEVICE SHOULD HAVE INFORMED ME OF THE LEGALITIES INVOLVED IN SUCH A PURCHASE. AS OF TODAY, I HAVE NOT HEARD BACK FROM ERCHONIA WHO TOLD ME THAT THEY COULD NOT LOCATE ANY PRESCRIPTIONS OR DRS ORDERS ON FILE AND THE SALES REP WHO SOLD IT TO ME WAS NO LONGER WITH THE COMPANY AND THEY WOULD NEED TO RESEARCH IT FURTHER AND WOULD CALL ME BACK. NOW, I AM STUCK WITH THIS DEVICE THAT HAS NEVER WORKED AND COMPLICATED TO USE. AT THIS POINT, I NEED YOUR ADVICE WHAT TO DO ABOUT THIS SITUATION, SINCE ERCHONIA SHOULD NOT HAVE SOLD THIS DEVICE TO ME IN THE FIRST PLACE. I WAS REFERRED TO YOU BY (B)(6) IN THE (B)(6) DIVISION, THAT YOU COULD BETTER ASSIST ME. PLEASE ADVISE. YOUR INTEREST IN CONTACTING THE US FOOD AND DRUG ADMINISTRATION, FDA, THROUGH YOUR RECENT EMAIL IS APPRECIATED. MY RESEARCH INTO OUR MEDICAL DEVICE DATABASE SHOWS THAT THE ERCHONIA LASER SYSTEMS ARE INDEED PRESCRIPTION ONLY MEANING THAT THEY ARE ONLY AVAILABLE ON THE ORDER OF A PHYSICIAN. YOU CAN SEE A SAMPLE OF THE INDICATIONS AND RESTRICTIONS AT HTTP://WWW.ACCESSDATA.FDA.GOV/CDRH_DOCS/PDF/K012580.PDF WITH THE PRESCRIPTION USE CATEGORY CHECKED OFF AT THE CONCLUSION OF THE DOCUMENT. YOU SHOULD ALSO BE AWARE THAT FDA FROWNS ON THE SALE OF PRESCRIPTION DEVICES OVER THE INTERNET, AS SUCH TRANSACTIONS ARE FRAUGHT WITH POTENTIAL PROBLEMS. IN FACT, TO LEGALLY SELL RX DEVICES, THE SELLER MUST BE AUTHORIZED BY THEIR STATE TO DISPENSE PRESCRIPTION DEVICES AND THE BUYER MUST PROVIDE A PRESCRIPTION. MORE RELATED INFO ABOUT ONLINE PURCHASES IS POSTED AT OUR WEBSITE OF HTTP://WWW.FDA.GOV/FORCONSUMERS/CONSUMERUPDATES/UCM048396.HTM. HOW TO OBTAIN ANY SATISFACTION FROM THE COMPANY IS PROBLEMATIC BUT I WOULD SUGGEST THAT YOU REPORT THIS SITUATION TO THE FDA MEDWATCH PROGRAM THROUGH ITS TOLL FREE NUMBER OF 800-FDA-1088 OR ONLINE THROUGH HTTP://WWW.FDA.GOV/SAFETY/MEDWATCH/DEFAULT.HTM. HOPEFULLY, THIS RESPONSE WILL BE OF ASSISTANCE AND YOU ARE WISHED THE BEST IN THE MANAGEMENT OF THE FAMILY HEALTH CARE! (B)(6) OFFICE OF COMMUNICATION, EDUCATION AND RADIATION PROGRAMS, CENTER FOR DEVICES AND RADIOLOGICAL HEALTH, U.S. FOOD AND DRUG ADMINISTRATION, 1-800-638-2041.