MalfunctionFMC
3612 LITE GLOVE
Received Nov 2, 2016
Report 9612030-2016-00595 · MDR key 6072275
Device
Product problems
- Device Damaged Prior to Use
- 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 REPORTS 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) IT WILL TEAR EXACTLY ALONG THIS MOLD LINE WHEN PUTTING IT OVER THE LIGHT ADAPTER.