InjuryNHN
TRISTAR ONE- PHOTONS SYSTEM
Received Jul 31, 2019 · Event occurred Jul 24, 2019
Report MW5088700 · MDR key 8857086
Device
Generic name
Powered Light Based Laser Non-thermal Instrument With Non-heating Affect For Adj
Manufacturer
Tristar OneProduct problems
- Therapeutic or Diagnostic Output Failure
Patient
60 YR
- Rash
- Rash
Narrative
Description of Event or Problem
AFTER USING AN LED LIGHT THERAPY DEVICE PURCHASED ON (B)(6), I HAVE DEVELOPED A SEVERE RASH REQUIRING CORTISONE TREATMENT. IT HAS ALSO TRIGGERED MY ASTHMA WHICH HAS ALSO REQUIRED TREATMENT WITH A STEROID. DID THE PROBLEM STOP AFTER THE PERSON REDUCED THE DOSE OR STOPPED TAKING OR USING THE PRODUCT? NO. DATE THE PERSON FIRST STARTED TAKING OR USING THE PRODUCT: (B)(6) 2019. DATE THE PERSON STOPPED TAKING OR USING THE PRODUCT: (B)(6) 2019. WHY WAS THE PERSON USING THE PRODUCT? TREATING SUN DAMAGE ON ARMS.