ANCILLARY, HEADBAND UL PLUS BI
Received Aug 22, 2014
Report 1222895-2014-00020 · MDR key 4077371
Device
Product problems
- Thermal Decomposition of Device
- Overheating of Device
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.
Description of Event or Problem
CUSTOMER INITIALLY REPORTS A PERSON USING INTEGRA HEADLIGHT SUFFERED A BURN TO THE HEAD FROM THE MODULE MEETING WHEN USING OUR MLX LIGHT SOURCE. (B)(4) 2014, REGIONAL BUSINESS MANAGER FOR INTEGRA REPORTED THAT THE HOSPITAL RISK MANAGER INFORMED HIM THAT THERE WAS NO BURN TO ANYONE, NO HARM DONE. (B)(4) 2014, DEALER CONFIRMS THIS IS THE DEVICE THAT BURNED THROUGH THE MELTING. (B)(4)2014, ALTHOUGH RISK MANAGER PROMISED ANSWERS TO EMAIL, NONE RECEIVED YET. NUMBER 1 OF 3 DEVICES REPORTED.