inforMED
InjuryQAI

DERMANI MEDSPA

Received May 11, 2023 · Event occurred Apr 17, 2023

Report MW5117498 · MDR key 16919826

Device

Generic name

Powered Microneedle Device

Manufacturer

Unknown

Product problems

  • Use of Device Problem

Patient

59 YR · Female

  • Fatigue
  • Pain
  • Ambulation or Postural Difficulties
  • Swelling/ Edema
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
  • Fatigue
  • Pain
  • Ambulation or Postural Difficulties
  • Swelling/ Edema
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

Narrative

Description of Event or Problem

I STARTED SKIN TIGHTENING TREATMENTS FOR MY NECK AT (B)(6) ON (B)(6) 2023. AFTER THE THIRD TREATMENTS I EXPERIENCED UNUSUAL DAILY FATIGUE AND SHORTLY AFTERWARDS MY FEET, LEGS, AND THIGHS BECAME EXTREMELY SWOLLEN. RIGHT NOW THE SWELLING IS SO SEVERE IT IS PAINFUL AND A STRUGGLE FOR ME TO WALK. WORST OF ALL MY DOCTOR AT (B)(6) HAS DIAGNOSED ME WITH GRAVES¿ DISEASE DUE TO HIGH TSH TEST RESULTS. DURING THE EXAM THE DOCTOR NOTED NODULES ON MY THYROID. I HAVE NEVER EXPERIENCED ANY OF THE CONDITIONS MENTIONED ABOVE PRIOR TO THESE TREATMENTS. BEFORE I AGREED TO THE TREATMENTS I ASKED THEM IF THE TREATMENT COULD IMPACT MY THYROID. THE (B)(6) ESTHETICIANS ASSURED ME THE TREATMENT WAS FDA APPROVED AND WAS USED SAFELY FOR YEARS. THAT HAS NOT BEEN MY EXPERIENCE AND THE TREATMENT HAS SERIOUSLY IMPACTED MY HEALTH. (B)(6) ADVERTISES PROFESSIONAL GRADE FDA CLEARED DEVICE FOR RADIOFREQUENCY MICRONEEDLING.