MalfunctionFMC
3612 LITE GLOVE
Received Nov 30, 2016
Report 9612030-2016-00753 · MDR key 6136006
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 AN ISSUE OCCURRED WITH A LITE GLOVE. THE CUSTOMER REPORTS GLOVES TEAR AT PULLING OVER HANDLE. THE LITE GLOVE WAS TOO TIGHT WHEN PLACING ON THE DEVON HANDLE. THE TEAR WAS FOUND DURING SET UP AND A NEW GLOVE WAS PLACED. NO PATIENT INVOLVED. SAMPLE WILL BE RETURNED.