InjuryISD

EXERCISER, MEASURING

Received Oct 27, 2023

Report MW5147441 · MDR key 18032798

Device

Generic name

Exerciser, Measuring

Manufacturer

Actigraph, Llc

Model number

ACTIGRAPH GT9X

Patient

Unknown

Partial thickness (Second Degree) Burn
Partial thickness (Second Degree) Burn

Narrative

Description of Event or Problem

LEGAL COMPLAINT, PATIENT VOLUNTEERED FOR THE ACDC STUDY CONDUCTED BY MEDTRONIC. THE PATIENT SUFFERED SECOND DEGREE BURNS ON THEIR CHEST FROM A NON-MEDTRONIC DEVICE. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).