MalfunctionFMC
NS-3600-B LITE GLOVE 1000/CASE
Received Nov 14, 2016
Report 9612030-2016-00641 · MDR key 6099309
Device
Product problems
- Torn Material
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
SUBMIT DATE: 11/14/2016. 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 GLOVE IS SPLITTING WHEN THE USED TRIES TO USE IT.