MalfunctionFMC
3611 LITE GLOVE
Received Feb 1, 2017
Report 9612030-2017-00053 · MDR key 6294609
Device
Product problems
- Torn Material
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
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) 2017 THAT AN ISSUE OCCURRED WITH A LITE GLOVE. THE CUSTOMER REPORTS THAT THE DEVICE TORE OFF THE ENTIRE LENGTH OF THE PRODUCT DURING APPLICATION.