EXCITEOSA
Received May 14, 2021 · Event occurred Apr 13, 2021
Report MW5101367 · MDR key 11831450
Device
Generic name
Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstruct
Manufacturer
Signifier Medical Technologies LlcProduct problems
- Melted
Patient
Not reported
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
A CUSTOMER LEFT THEIR CONTROL UNIT TO CHARGE OVERNIGHT WITH THE SUPPLIED USB CABLE. WHEN THEY ATTENDED TO THE CONTROL UNIT AFTER HOURS OF CHARGING (ON (B)(6) 2021), THEY FOUND THAT THE CONTROL UNIT AND CABLE WAS HOT AND HAD MELTED SLIGHTLY AT THE CONNECTION POINT. FDA SAFETY REPORT ID # (B)(4).