MalfunctionFMC
3612 LITE GLOVE
Received Nov 21, 2016
Report 9612030-2016-00671 · MDR key 6116942
Device
Product problems
- Out-Of-Box Failure
- Torn Material
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
AN INVESTIGATION IS CURRENTLY UNDER WAY; 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 LIGHT GLOVE. THE CUSTOMER REPORTS: THE GLOVES HAVE CUTS RIGHT OUT OF THE PACKAGING.