MalfunctionFMC
3612 LITE GLOVE
Received Nov 11, 2016
Report 9612030-2016-00639 · MDR key 6096657
Product problems
- Torn Material
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
AN INVESTIGATION IS CURRENTLY UNDER WAY; UPON COMPLETION THE RESULTS WILL BE FORWARDED.
Description of Event or Problem
IT WAS REPORTED TO COVIDIEN ON (B)(6) 2016 THAT THE CUSTOMER EXPERIENCED 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. NO PATIENT INVOLVED.