LOUISE WALSH PLASMA PEN
Received Jun 19, 2020 · Event occurred Mar 7, 2020
Report MW5095108 · MDR key 10179046
Device
Generic name
Powered Microneedle Device
Manufacturer
Louise Walsh InternationalProduct problems
- Adverse Event Without Identified Device or Use Problem
Patient
33 YR
- Cyst(s)
- Erythema
- Skin Discoloration
- Impaired Healing
- Cyst(s)
- Erythema
- Skin Discoloration
- Impaired Healing
Narrative
Description of Event or Problem
I WENT TO AN AESTHETICIAN TO HAVE A PLASMA PEN (ALSO KNOWN AS FIBROBLAST) TREATMENT DONE ON MY PERIORBITAL WRINKLES. THE PROCEDURE WAS DONE ON MARCH 7TH, AND THE AESTHETICIAN USED A LOUISE WALSH PLASMA PEN. THE TREATMENT LEFT POCK MARKS WHERE EACH "CARBON CRUST" WAS AS WELL AS A RED MARK AT THE SITE OF EACH ONE. THE HEALING PROCESS WAS SUPPOSED TO ONLY TAKE A WEEK, BUT MINE TOOK 3. I REACHED TO THE AESTHETICIAN WHO TOLD ME SHE'S SEEN THIS HAPPEN OFTEN AND I NEEDED TO COME BACK IN, SO SHE CAN DO ANOTHER TREATMENT BUT WITH A DIFFERENT TECHNIQUE ONCE 3 MONTHS HAD PASSED. AS THE WEEKS WENT ON, SOME OF THE INDENTATIONS POPPED OUT AND BECAME BUMPS, 3 SMALL CYSTS AROSE IN THE AREA, AND THE CONDITION DIDN'T IMPROVE. I WENT TO A DERMATOLOGY OFFICE AFTER DOING MUCH RESEARCH TO INQUIRE ABOUT MY OPTIONS INVOLVING LASERS. AT THE ADVICE OF THE RN WORKING UNDER A DERMATOLOGIST, I HAD A FRAXEL DUAL LASER TREATMENT ON MAY 29TH AND ANOTHER ON THE 15TH OF THIS MONTH (JUNE) TO CORRECT THE MARKS, DISCOLORATION, AND SMALL CYSTS. THE FIRST TREATMENT HELPED A GREAT DEAL, AND I ANTICIPATE THIS WILL BE THE LAST FRAXEL TREATMENT I NEED TO CORRECT THE INDENTATIONS. ACCORDING TO THE RN, THE REDNESS IS FROM BROKEN CAPILLARIES CAUSED BY THE PEN AND IT REQUIRES A DIFFERENT TYPE OF LASER CALLED THE V BEAM. I WILL NEED TO UNDERGO ONE TREATMENT OF V BEAM TO CORRECT THE DISCOLORATION. THE PLASMA PEN COST ME BETWEEN $(B)(6); THE TWO FRAXEL TREATMENTS AND THE V BEAM TREATMENT TO CORRECT THE DAMAGE FROM THE PLASMA PEN COST ME A TOTAL OF $(B)(6)NOT INCLUDING THE CREAMS NEEDED TO AID IN HEALING AND THE 2.5 HOUR ROUND-TRIP DRIVES I MAKE EACH TIME I GO. I CAN PROVIDE PHOTOS OF THE DAMAGE DONE TO MY EYES AS WELL AS THE BUSINESS INFORMATION OF WHERE I GOT IT DONE. FDA SAFETY REPORT ID# (B)(4).