DERMAPEN
Received Jan 4, 2023 · Event occurred May 20, 2021
Report MW5114185 · MDR key 16103999
Device
Generic name
Powered Microneedle Device
Manufacturer
UnknownProduct problems
- Improper or Incorrect Procedure or Method
Patient
48 YR · Female
- Bruise/Contusion
- Erythema
- Hemorrhage/Blood Loss/Bleeding
- Pain
- Scar Tissue
- Fluid Discharge
- Localized Skin Lesion
- Hyperpigmentation
- Bruise/Contusion
- Erythema
- Hemorrhage/Blood Loss/Bleeding
- Pain
- Scar Tissue
- Fluid Discharge
- Localized Skin Lesion
- Hyperpigmentation
Narrative
Description of Event or Problem
I HAD MY THIRD DERMAPEN TREATMENT WITH A CONSULTANT DERMATOLOGIST IN (B)(6). I WANTED TREATMENT FOR A FEW BOTHERSOME ACNE SCARS AND THE DERMATOLOGIST SAID THIS WOULD BE THE BEST TREATMENT FOR ME. I WAS VERY NERVOUS ABOUT DOWNTIME BUT WAS ASSURED THERE WOULD BE MINIMAL DOWNTIME. MY FIRST TWO TREATMENTS WERE FINE AND I HAD SOME REDNESS WHICH FADED BY DAY 2. ON THE THIRD TREATMENT, I FELT MUCH MORE RELAXED AS I KNEW WHAT TO EXPECT. I WAS ASKED HOW MY SKIN WAS, AND I SAID IT WAS NICE AND GLOWY BUT I COULDN'T SEE A DIFFERENCE WITH MY SCARS. THE DERMATOLOGIST SAID THAT IF I DIDN'T SEE ANY RESULTS ON THE SCARS THEN THERE WAS NO POINT IN CARRYING ON WITH THE TREATMENTS. THE DERMATOLOGIST WENT ON TO CARRY OUT A VERY AGGRESSIVE TREATMENT, I COULD TELL IT WAS A LOT MORE PAINFUL EVEN WITH THE NUMBING CREAM. I DIDN'T SAY ANYTHING, AS I TRUSTED WHAT SHE WAS DOING. AFTER THE TREATMENT SHE PLACED ICE ON MY FACE WHICH I HADN'T HAD IN MY PREVIOUS TREATMENTS. MY SKIN WAS RED RAW, BLEEDING AND WEEPING WITH A HOLE ON THE RIGHT SIDE OF MY CHEEK. I WAS IN SHOCK. THE NEXT DAY MY SKIN WAS BRUISED, WITH DRIED BLOOD, SCABS AND OPEN WOUND STILL ON MY RIGHT CHEEK. IT TOOK 5 DAYS FOR THE SCABS TO FALL OFF, AFTER WHICH I WAS LEFT WITH PINK AND VERY SENSITIVE SKIN. A COUPLE OF WEEKS LATER, MY SKIN BECAME HYPERPIGMENTED (I HAVE DARK SKIN TONE) AND WAS VERY SENSITIVE AND NUMB IN PLACES. I COULD ALSO SEE SOME TRACK MARKS FROM THE NEEDLE BEING DRAGGED BUT THE HYPERPIGMENTATION WAS MY MAIN CONCERN THEN. I WENT TO SEE THE DOCTOR WHO ASSURED ME THE HYPERPIGMENTATION WOULD GO BUT SHE WAS ALSO VERY UNSYMPATHETIC. THE HYPERPIGMENTATION TOOK ABOUT 1 YEAR TO GO, AFTER USING TRETINOIN FOR A SHORT WHILE (I COULD NOT CONTINUE TO USE IT AS MY SKIN BARRIER WAS SO DAMAGED AND IT WAS VERY IRRITATING TO MY SKIN). SINCE THE HYPERPIGMENTATION CLEARED AROUND MAY 2022, THE INDENTED MICRO HOLES, TRACK MARKS AND LINEAR INDENTATION BECAME MORE NOTICEABLE. MY ORIGINAL SCARRING HAS NOT IMPROVED AT ALL, BUT IN FACT I HAVE BEEN LEFT WITH MORE PERMANENT SCARRING ALL OVER WHERE THE NEEDLING WAS DONE. THE DERMATOLOGIST HAS NOT TAKEN ANY RESPONSIBILITY FOR IT, AND ISN'T ACKNOWLEDGED I HAVE SCARRING FROM THE NEEDLES. I SUBSEQUENTLY FOUND OUT THAT SHE USED 3MM DERMAPEN NEEDLE. MY FACE HAS BEEN SCARRED BY THIS DEVICE AND I CANNOT BELIEVE THIS WAS DONE BY A CONSULTANT DERMATOLOGIST. AGGRESSIVE USE OF THE DERMAPEN AT A 3MM LENGTH SHOULD BE BANNED. PLEASE LET ME KNOW WHAT MY RESOURCES ARE? I DON'T HAVE TESTS, I HAVE PHOTOS OF MY SKIN AFTER THE THIRD NEEDLING.