inforMED
InjuryNFO

NUFACE TRINITY+

Received Apr 11, 2024 · Event occurred Apr 1, 2024

Report MW5153785 · MDR key 19097090

Device

Generic name

Stimulator, Transcutaneous Electrical, Aesthetic Purposes

Lot number

DHR2964

Patient

35 YR · Female

  • Arrhythmia
  • Dyspnea
  • Nausea
  • Discomfort
  • Arrhythmia
  • Dyspnea
  • Nausea
  • Discomfort

Narrative

Description of Event or Problem

I AM A 35-YEAR-OLD FEMALE WITH NO EXISTING HEALTH CONDITIONS. I STARTED USING NUFACE FIRST WEEK OF (B)(6). AFTER TWO WEEKS, I STARTED NOTICING SOME INTERMITTENT CHEST DISCOMFORT AND POUNDING OF MY HEART. IT PROGRESSED TO THE POINT THAT IN THE PAST FEW DAYS, IT HAS BEEN CONSTANT AND I'VE BEEN SYMPTOMATIC (NAUSEA, SHORTNESS OF BREATH). I AM NOW WEARING A 7-DAY RHYTHM MONITOR TO ASSESS THE ACTUAL RHYTHM, BUT IT IS CONFIRMED IRREGULAR ON PHYSICAL EXAM. I BELIEVE THE NUFACE DEVICE CONTRIBUTED TO THIS. ALL MY BLOODWORK (CBC, CMP, MAGNESIUM) HAS BEEN FINE AS OF (B)(6) 2024. I AM RETURNING THE DEVICE TO GET A REFUND AND ALSO CONTACTING THE FDA AND THE COMPANY.