inforMED
MalfunctionPMV

BEACTIVE PLUS

Received Dec 23, 2022

Report MW5114005 · MDR key 16051268

Device

Generic name

Orthosis, Limb, For Back Pain

Product problems

  • Output Problem

Patient

53 YR · Male

  • Insufficient Information
  • Insufficient Information

Narrative

Description of Event or Problem

HTTPS://WWW.GETBEACTIVEPLUS.CA/. CLAIMS THAT THE PRODUCT IS FDA APPROVED AS A BREAKTHROUGH PAIN DEVICE. CANNOT FIND ANYTHING ON FDA WEBSITE TO SUBSTANTIATE THIS CLAIM. ORDERED THE PRODUCT AND DOES NOT WORK AT ALL.