MalfunctionFMC
3612 LITE GLOVE
Received Oct 28, 2016
Report 9612030-2016-00570 · MDR key 6064980
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
SUBMIT DATE: 10/28/2016. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem
IT WAS REPORTED TO COVIDIEN ON 10/19/2016 THAT AN ISSUE OCCURRED WITH A LITE GLOVE. THE CUSTOMER REPORTS THAT THE LIGHT GLOVE HAS A TEAR OUT OF THE PACKAGING ALONG THE HANDLE. THE CUSTOMER NOTED A VISIBLE LINE IN THE PLASTIC (LIKE A MOLD) AND IF THE HANDLE IS NOT ALREADY OPEN OUT OF THE PACKAGING, IT WILL TEAR EXACTLY ALONG THIS "MOLD" WHEN PUTTING IT OVER THE LIGHT ADAPTER.