Description of Event or Problem · 1
RE: PORTRAIT PLASMA SKIN RESURFACING SYSTEM (PSR3). ON (B)(6) 2010, I RECEIVED PLASMA SKIN RESURFACING (PSR3) AT DR. (B)(6) OFFICE, DERMATOLOGIST; (B)(6). MY MEDICAL NOTES SAY 3.7 J/1.5 HZ FOR TREATMENT. (B)(6), WHO WORKS FOR (B)(4) IS THE PERSON WHO GAVE ME THE TREATMENT. (B)(6). APPARENTLY, THIS LASER COMPANY, RENTS EQUIPMENT TO VARIOUS DR'S OFFICES, AND SENDS THE TECH ALONG TO DO THE PROCEDURE. THE FORM (B)(6) HAD ME SIGN ON (B)(6) 2010, HAS ANOTHER DR'S NAME ON IT, WHO ALSO, RENTS LASERS FROM (B)(4). MY CHECK WAS PAID TO DR. (B)(6), THE PROCEDURE WAS DONE AT HIS OFFICE AND PERFORMED BY (B)(6). DR. (B)(6) OFFICE SENT ME MY MEDICAL NOTES, WHICH SHOWED THE TREATMENT WAS AT HIS OFFICE ON (B)(6) 2010 (CONSENT FORM FOR PORTRAIT PSR3, (B)(6). AFTER THE PLASMA TREATMENT ON (B)(6) 2010, MY FACE WAS INCREDIBLY RED, SPOTS REMAINED ON MY FACE FOR WEEKS. A FEW MONTHS AFTER THE SPOTS DIMINISHED, THERE WERE SOME ALARMING CHANGES IN MY FACE, HOLLOWNESS UNDER MY EYES (THE FAT UNDER MY LOWER LID AND OTHER AREAS OF MY FACE, HAD GREATLY DIMINISHED) TEAR TROUGHS FORMED, AND OVERALL, MY SKIN WAS SAGGING. MY EYES STARTED BOTHERING ME, THEY WERE ACHING AND WATERING AND FELT LIKE EXTRA AIR WAS HITTING THEM. I WENT TO MY EYE DR WHO TOLD ME I HAVE RETRACTION OF MY LOWER LID, SCLERA SHOW. HE SAID IT WAS PROBABLY RELATED TO THE PLASMA TREATMENT. I VISITED DR. (B)(6), PLASTIC SURGEON IN (B)(6), I SHOWED HIM MY BEFORE AND AFTER PICTURES, HE SAID THE ENERGY WOULD HAVE HAD TO BEEN EXTREMELY HIGH FOR THE TREATMENT TO CAUSE THAT TYPE OF A CHANGE IN FACE, MORE ENERGY THAN 3.7 J. (B)(6). WHEN I STARTED HAVING PROBLEMS WITH MY FACE, I PULLED OUT THE BROCHURE AND READ IT OVER AGAIN I TRIED TO ACCESS THE WEB SITE REFERRED TO ON THE FRONT, (B)(6) IT DOES NOT EXIST. I THEN CALLED THE PHONE NUMBER ON THE FRONT OF THE BROCHURE, (B)(6), IT IS NOT IN SERVICE. I DUG DEEPER AND FOUND OUT THE COMPANY THAT MADE THIS MACHINE FILED BANKRUPTCY, (B)(6) 2008 (B)(6). WHEN I WAS RESEARCHING INFO ON (B)(6), I CAME ACROSS A WARNING LETTER FROM FDA, IN (B)(6), TO (B)(6), (B)(4). THIS LETTER IS DATED (B)(6) 2007, AND SITES SEVERAL PROBLEMS WITH THE PSR3. PAGE 2 OF 3, UNDER NUMBER 6, "A TRAINING PROCEDURE HAS NOT BEEN DEVELOPED FOR SALES REPS AND CONTRACT SALES PERSONNEL ON HOW TO SAFELY AND EFFECTIVELY INSTRUCT PHYSICIANS IN THE USE OF THE DEVICE." THE LAST PAGE OF THIS LETTER, THIRD SENTENCE STATES "OUR INSPECTION ALSO REVEALED THAT IN (B)(6) 2006 YOU MODIFIED THE SOFTWARE OF THE PORTRAIT PSR3 SYSTEM TO AFFECT THE POWER LEVEL OUTPUT OF THE DEVICE. THIS MODIFICATION CONSTITUTES A SIGNIFICANT CHANGE OR MODIFICATION THAT COULD SIGNIFICANTLY AFFECT THE SAFETY OR EFFECTIVENESS OF THE DEVICE" (B)(6). I CALLED (B)(6), COMPLIANCE OFFICER, HE TOLD ME HIS FILE DOES NOT SHOW THE PROBLEMS SITED IN THE LETTER WERE CORRECTED, THE COMPANY FILED BANKRUPTCY AND NOTHING ELSE WAS DONE. I SENT A LETTER TO FDA, PURSUANT TO THE FREEDOM OF INFORMATION ACT, REQUESTING ANY PERTINENT RECORDS RELATING TO THE (B)(4), THE PSR3 AND ANY FOLLOW UPS OF COMPLAINT LETTER (B)(6). THE WAY I UNDERSTAND IT, PAGE 1 OF 6, THE SUMMARY, STATES THE INSPECTION ON (B)(4) 2008, WAS AN ABBREVIATED INSPECTION, ADDRESSING, SPECIFICALLY, F/U TO HOW THE COMPANY WILL COVER CUSTOMER COMPLAINTS. ON PAGE 2 OF 6 UNDER CLASS II RECALL, IT STATES 8 OF THE 12 WERE CORRECTED. THE INSPECTION ON (B)(4) 2008, RESULTED IN A 4 ITEM FDA-483. PAGE 5 OF 6, RECALL PROCEDURES: NO INFO WAS PROVIDED FOR THE HANDLING OF ANY CORRECTIONS OR REMOVAL FOR THE EXISTING APPROX 300 UNITS THAT ARE CURRENTLY LOCATED IN THE (B)(4), SHOULD A SITUATION COME TO PASS. THE INFO FROM THE (B)(4) 2008 INSPECTION STATES ACCORDING TO (B)(4), (-------) PLASMA SKIN RESURFACING GENERATORS AND DEMOS RESIDE WITH THEIR SALES REPS. PAGE 4, LAST PARAGRAPH, SPEAKS ABOUT THE DELIVERY COMPANY HAVING A DEVICE IN THEIR POSSESSION. FROM MY UNDERSTANDING OF THIS LETTER, THE PROBLEMS SITED IN THE WARNING LETTER WERE NOT CORRECTED, AND THERE ARE UNSAFE MACHINES OUT IN CIRCULATION BEING USED. AS MR. (B)(6) STATED, SINCE THE COMPANY FILED BANKRUPTCY, NOTHING MORE WAS DONE. ON (B)(6) 2010, I GOOGLED INFO ON (B)(4), THE COMPANY WHO RENTS THESE MACHINES TO DRS. (B)(6). UNDER AVAILABLE LASERS, THERE IS A PARAGRAPH ABOUT PLASMA (B)(6). NO DISCUSSION OF HIGH OR LOW ENERGY TREATMENTS. UNDER REVENUE PROJECTIONS, IT STATES PLASMA SKIN REJUVENATION LOW ENERGY TX, (B)(4), 30 MINUTES, MOST TREATMENTS ARE PERFORMED BY THE PHYSICIAN. I PAID FOR HIGH ENERGY (B)(6), THE SITE DOES NOT EVEN LIST HIGH ENERGY AS A TREATMENT THEY OFFER. I JUST PRINTED UP THE INFO AGAIN TODAY, (B)(6) 2011, STILL NO PICTURE OF THE PLASMA OR ANY MENTION OF OFFERING HIGH ENERGY TREATMENTS (B)(6). WHEN I RECENTLY MET WITH (B)(6) AND DR. (B)(6) REGARDING THE DAMAGE TO MY FACE FROM THE PLASMA TREATMENT, (B)(6) INFORMED ME SHE IS WELL TRAINED IN THE USE OF THE PSR3, AND SHE TRAINS PHYSICIANS ON HOW TO USE IT. (B)(6) SENT ME AN E-MAIL (B)(6) 2010, A COUPLE DAYS AFTER SHE TREATED MY FACE WITH THE PLASMA PORTRAIT PSR. "I'M SURE YOUR FACE IS PROGRESSING BEAUTIFULLY. YOU WILL LOOK AMAZING WHEN THIS IS ALL OVER." IF THIS PERSON IS WELL TRAINED IN THE USE OF THIS MACHINE, THEN THERE HAS TO BE A MALFUNCTION OF THE MACHINE ITSELF. I HAVE SPENT CONSIDERABLE TIME AND MONEY, CONSULTING BOTH DERMATOLOGIST AND PLASTIC SURGEONS REGARDING THE CHANGES IN MY FACE CAUSED FROM THE PORTRAIT PSR3. I HAVE BEEN TOLD, THE ENERGY SETTING 3.7 J WOULD NOT HAVE AFFECTED MY FACE IN THIS MANNER. I HAVE MANY QUESTIONS: ARE THERE TWO TYPES OF PLASMA MACHINES, ONE HIGH ENERGY AND ONE LOW ENERGY? ARE THERE SOME MACHINES SAFE, SOME NOT? THE LETTER I RECEIVED FROM FDA STATES 8 OF THE 12 WERE CORRECTED, WHERE ARE THE OTHER 4? (B)(4) SAID (BLANK) NUMBER OF SKIN RESURFACING GENERATORS AND DEMOS RESIDE WITH THEIR SALES REP, ARE THEY STILL WITH THE SALES REP? IS THE SALES REP (B)(6) OR SOMEONE HAVING SOMETHING TO DO WITH (B)(4)? WHAT ABOUT THE OPERATOR THAT INVESTIGATOR (B)(4) SPOKE WITH, FROM ONE OF THE DELIVERY COMPANIES (B)(6) SHE STATED SHE HAD A DEVICE IN HER POSSESSION AND WAS WAITING FOR A PHONE CALL WITH FURTHER INSTRUCTIONS, WHAT HAPPENED TO THIS DEVICE? CAN YOU PLEASE TELL ME, WAS A TRAINING PROCEDURE DEVELOPED FOR SAFE INSTRUCTIONS ON HOW TO USE (B)(4) PORTRAIT PSR3? HAS THIS COMPANY RENTING OUT THE MACHINES AND THEIR TECH'S RECEIVED FDA APPROVED TRAINING ON THE SAFE OPERATION OF THE PORTRAIT PSR3? I CAN'T UNDO WHAT HAPPENED TO ME, BUT I WOULD LIKE TO PREVENT IT FROM HAPPENING TO SOMEONE ELSE. I ASK YOU TO PLEASE, INVESTIGATION THE PSR3, WHICH WAS USED ON MY FACE (B)(6) 2010, TO MAKE SURE THIS IS NOT A FAULTY MACHINE. FROM READING THE INFO ON THE PSR3, IT HAS A SOFTWARE PROGRAM, I AM SURE THIS SOFTWARE PROGRAM CAN GIVE THE DETAILS OF WHAT HAPPENED WITH THE MACHINE.