MalfunctionFMC
3611 LITE GLOVE
Received Nov 23, 2016
Report 9612030-2016-00728 · MDR key 6124844
Device
Product problems
- Device Damaged Prior to Use
- Out-Of-Box Failure
- Torn Material
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
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 10/26/2016 THAT A CUSTOMER HAD AN ISSUE WITH LITE GLOVES. THE CUSTOMER REPORTS THAT THREE LITE GLOVES WERE FOUND TORN INSIDE THE PACKAGING. NO PATIENT INVOLVED.