ANCILLARY, HEADBAND UL PLUS BI
Received Aug 22, 2014
Report 1222895-2014-00021 · MDR key 4077355
Device
Product problems
- Melted
Patient
Not reported
- Burn(s)
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 MELTING 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 A MELTING MODULE. (B)(4) 2014, ALTHOUGH RISK MANAGER PROMISED ANSWERS TO EMAIL, NONE RECEIVED YET. NUMBER 2 OF 3 DEVICES REPORTED.