MalfunctionPQY

ACTIPATCH

Received Nov 7, 2025

Report MW5178629 · MDR key 23497822

Device

Generic name

Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The T

Manufacturer

Bioelectronics Corporation

Product problems

Delivered as Unsterile Product
Packaging Problem

Patient

NA · Male

No Clinical Signs, Symptoms or Conditions
No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

SOME KIND OF BUG/INSECT FECAL MATTER IN DEVICE PACKAGING. TRAVELED ALL THE WAY TO MANUFACTURER ADDRESS FROM (B)(6) AND FOUND OUT MANUFACTURER IS NO LONGER AT THE BUILDING. ONLINE INFORMATION ON MANUFACTURER WEBSITE OR FDA DOES NOT STATE ANY NEW MANUFACTURER ADDRESS. PHONE CALL UNANSWERED.