MalfunctionFMR
RAYE'S, INC DBA SIZEWISE MANUFACTURING
Received Dec 30, 2025 · Event occurred May 29, 2025
Report 1954156-2025-00014 · MDR key 23926998
Device
Product problems
- Electrical Overstress
- Electrical Overstress
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
A CORRECTIVE AND PREVENTIVE ACTION CAPA-01205 HAS BEEN INITIATED TO THOROUGHLY INVESTIGATE THE ISSUE AND IDENTIFY THE ROOT CAUSE.
Description of Event or Problem
DEVICE WAS SENT IN FOR REPAIR AND UPON OPENING THE UNIT, THE TECHNICIAN FOUND BURN DAMAGE INTERNALLY.