MalfunctionFMC
LITE GLOVE
Received Nov 29, 2016
Report 9612030-2016-00744 · MDR key 6132160
Device
Product problems
- Torn Material
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
SUBMIT DATE: 11/29/2016. 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 LITE GLOVES. THE CUSTOMER STATES THAT SINCE THE NEW PACKAGING, THERE WERE SEVERAL TORN LITE GLOVES FOUND INSIDE THE PACKAGING. NO PATIENT INVOLVED.