MalfunctionFMC
3612 LITE GLOVE
Received Sep 26, 2016
Report 9612030-2016-00462 · MDR key 5977873
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 REPORTS: LITE GLOVE TORE APART WHILE PULLING OVER ON ORIGINAL LITE GLOVE ADAPTER AT THE TIME OF THE SET UP, THE PATIENT WAS NOT PRESENT.