inforMED
MalfunctionILY

REJUVENATOR

Received Feb 7, 2019 · Event occurred Nov 1, 2018

Report MW5083858 · MDR key 8320872

Device

Generic name

Lamp, Infrared, Therapeutic Heating

Manufacturer

Unknown

Model number

UNIVERSAL#3

Product problems

  • Break
  • Defective Device
  • Noise, Audible

Patient

60 YR

  • Complaint, Ill-Defined
  • Complaint, Ill-Defined

Narrative

Description of Event or Problem

REJUVENATOR LIGHT DEVICE LED AND INFRARED. THEY ARE SAYING ON (B)(6) THAT THIS IS A GRADE 2 MEDICAL DEVICE. THE (B)(6) GROUP IS CLOSED. ALSO THEY ARE RECOMMENDING FOR USE ON THE EYES. ELSEWHERE DOCTORS ARE SAYING THAT LOOKING AT INFRARED IS BAD FOR THE RETINA. NEXT PROBLEM IS THAT THE LIGHT KEEPS BLINKING AND BUZZING. THE OWNER TOLD ME JUST TO GET A NEW CORD. I DID SO AND SAME PROBLEM WITH THE NEW CORD. IT¿S SUPPOSED TO HAVE A ONE YEAR WARRANTY, BUT SHE KEEPS SAYING IT¿S MY FAULT THAT I AM BREAKING THE CORDS. NOW I HAVE IT AT REPAIR SHOP. THEY ARE SAYING FAULTY SOLDERING ON THE SWITCH. A LOT OF PEOPLE ARE HAVING THIS ISSUE AND POSTING IT ON (B)(6). THE OWNER JUST DELETES THE POSTS. THIS PRODUCT SEEMS FAULTY, DANGEROUS, AND IS BEING PRESCRIBED WRONG. (B)(4).