MalfunctionFMC
3612 LITE GLOVE
Received Dec 19, 2016
Report 9612030-2016-00828 · MDR key 6187074
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 A LITE GLOVE. THE CUSTOMER STATES THAT THE LITE GLOVES ARE TEARING UP THE MIDDLES UPON APPLICATION TO THE DEVON LIGHT HANDLES. THE MATERIAL SEEMS TO DIFFER IN THICKNESS/DENSITY DEPENDING ON WHAT SECTION. THE SECTION THAT SLIPS ONTO THE HANDLES WHERE THE DAMAGE IS OCCURRING APPEARS TO BE MORE TRANSPARENT/THINNER THAN THE CUFF AND TIP.