MalfunctionFMC
3611 LITE GLOVE
Received Oct 4, 2016
Report 9612030-2016-00497 · MDR key 5997704
Device
Product problems
- Torn Material
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
SUBMIT DATE: 10/4/2016. 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 GLOVE TORE WHILE PULLING OVER THE HANDLE. THERE WAS NO PATIENT PRESENT, NO HARM.