MalfunctionFMC
3611 LITE GLOVE
Received Nov 21, 2016
Report 9612030-2016-00673 · MDR key 6117683
Device
Product problems
- Torn Material
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
SUBMIT DATE: 11/21/2016. 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 AN ISSUE OCCURRED WITH LITE GLOVES. THE CUSTOMER REPORTS AN ISSUE WITH TWO CARTONS OF LITE GLOVES. THE CUSTOMER REPORTS THAT THE GLOVES TEAR WHEN PULLED OVER THE LITE GLOVE HANDLE DURING SET UP. THE CUSTOMER REPORTS THE LITE GLOVE WAS TOO TIGHT SO A NEW GLOVE WAS PLACED. PATIENT WAS NOT IN THE ROOM. NO PATIENT INVOLVED.