MalfunctionFMC
3612 LITE GLOVE
Received Nov 22, 2016 · Event occurred Oct 10, 2016
Report 9612030-2016-00676 · MDR key 6121341
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 (B)(6) 2016 THAT A CUSTOMER HAD AN ISSUE WITH A LITE GLOVE. THE CUSTOMER STATES THAT WHILE PULLING THE LITE GLOVE OVER THE OP LAMP, THE LITE GLOVE RIPPED. THERE WAS NO REPORTED INJURY AND NO PATIENT IN THE ROOM.