MalfunctionFMC
3612 LITE GLOVE
Received Dec 5, 2016
Report 9612030-2016-00780 · MDR key 6145785
Device
Product problems
- Torn Material
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
AN INVESTIGATION IS CURRENTLY UNDER WAY. 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. CUSTOMER REPORTS: THE LITE GLOVE TORE AT THE HANDLE DURING USE. ADDITIONAL INFORMATION WAS REQUSTED ON 12/2/16 AND 12/5/16 WITH NO RESPONSE TO DATE.