MalfunctionFMC
3611 LITE GLOVE
Received Oct 31, 2016
Report 9612030-2016-00582 · MDR key 6068173
Device
Product problems
- Torn Material
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
AN INVESTIGATION IS CURRENTLY UNDER WAY; UPON COMPLETION THE RESULTS WILL BE FORWARDED.
Description of Event or Problem
IT WAS REPORTED TO COVIDIEN ON (B)(6) 2016 THAT A CUSTOMER HAD AN ISSUE WITH A LITE GLOVE. THE CUSTOMER REPORTS THE LIGHT GLOVE TORE APART AT SET UP. THERE WAS NO PATIENT INVOLVED.