MalfunctionFMC
3612 LITE GLOVE
Received Nov 22, 2016
Report 9612030-2016-00688 · MDR key 6122231
Device
Product problems
- Crack
- Out-Of-Box Failure
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. CUSTOMER REPORTS: FAILURE OUT OF BOX. AT UNPACKING THE CUSTOMER NOTICED THAT THE LITE GLOVE HAS A CRACK. NO USE POSSIBLE, NO PERSON INJURED, NO PATIENT INVOLVED.