MalfunctionFMC
3611 LITE GLOVE
Received Dec 9, 2016 · Event occurred Dec 6, 2016
Report 9612030-2016-00798 · MDR key 6157749
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) 2016 THAT A CUSTOMER HAD AN ISSUE WITH LITE GLOVES. THE CUSTOMER STATES THAT WHEN THEY ARE TRYING TO INSERT THE GLOVES, THEY ARE RIPPING OFF.