MalfunctionFMC
NS-3600-B LITE GLOVE 1000/CASE
Received Nov 29, 2016
Report 9612030-2016-00743 · MDR key 6131560
Device
Product problems
- Device Damaged Prior to Use
- Split
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 (B)(6) 2016 THAT AN ISSUE OCCURRED WITH A LITE GLOVE. CUSTOMER REPORTED ITEM WAS RECEIVED SPLIT.
Additional Manufacturer Narrative
SUBMIT DATE: 12/02/2016. ON (B)(6) 2016 THE CUSTOMER STATED THAT THE AFFECTED LOT NUMBER IS 6153107964. SECTION HAS BEEN UPDATED.