STRAWBERRY LASER
Received Feb 13, 2018 · Event occurred Jan 9, 2018
Report MW5075229 · MDR key 7269606
Device
Generic name
Strawberry Laser
Manufacturer
UnkProduct problems
- Patient-Device Incompatibility
Patient
Not reported
- Abdominal Pain
- Skin Discoloration
- Cramp(s)
- Abdominal Pain
- Skin Discoloration
- Cramp(s)
Narrative
Description of Event or Problem
(B)(6) OPERATING AS (B)(6) IS OPERATING AN FDA MEDICAL DEVICE AND IS NOT A DOCTOR, NOR DOES SHE HAVE A MEDICAL DOCTOR ON PREMISES. THEY ARE OPERATING OUT OF (B)(6). THEY HAVE SINCE CHANGED THEIR WEBSITE AND THEIR LITERATURE TO SAY THAT THEY ARE A MEDSPA WHICH THEY ARE NOT. I DID NOT FEEL WELL AFTER MY INITIAL VISIT. MY STOMACH HURT AND CRAMPED AND I HAD RED MARKS ON MY STOMACH. WHEN I ASKED TO SPEAK TO THE PHYSICIAN, I WAS TOLD THERE IS NO PHYSICIAN THAT SHE IS A CERTIFIED LASER TECHNICIAN.