MalfunctionFMC
3612 LITE GLOVE
Received Nov 22, 2016
Report 9612030-2016-00690 · MDR key 6122347
Device
Product problems
- Torn Material
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem
IT WAS REPORTED TO COVIDIEN ON 10/27/2016 THAT AN ISSUE OCCURRED WITH LITE GLOVES. THE CUSTOMER REPORTS LITE GLOVES THAT TEAR AT SET UP, NO PATIENT INVOLVED.