EXCITEOSA
Received Jun 28, 2021 · Event occurred Apr 13, 2021
Report 3017737771-2021-00001 · MDR key 12075118
Device
Generic name
Exciteosa
Manufacturer
Signifier Medical Technologies LtdModel number
3000Catalog number
3000
Lot number
N/A
Product problems
- Melted
- Overheating of Device
Patient
Not reported
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
USER 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.
Additional Manufacturer Narrative
REPORTED ON (B)(6) 2021 BY MANUFACTURER VIA FORM 3500A MEDWATCH DUE TO WEBTRADER ACCOUNT NOT BEING APPROVED YET, REFERENCE MW5101367. THIS REPORT IS BEING RESUBMITTED WITH A NEW MFR REPORT NUMBER AS IT WAS SUBMITTED WITH INCORRECT REPORT SEQUENCE NUMBER 3017737771-2021-00000 ON (B)(6) 2021.