MalfunctionFMC
3612 LITE GLOVE
Received Dec 5, 2016
Report 9612030-2016-00776 · MDR key 6145419
Device
Product problems
- Packaging Problem
- 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 (B)(6) 2016 THAT A CUSTOMER HAD AN ISSUE WITH LITE GLOVES. THE CUSTOMER STATES THAT WHEN OPENING THE PACKAGE, TWO LITE GLOVES WERE TORN. NO PATIENT INVOLVED.