MalfunctionFMC
3612 LITE GLOVE
Received Aug 24, 2016
Report 9612030-2016-00399 · MDR key 5902059
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
SUBMIT DATE: 08/24/2016. 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 A LITE GLOVE. THE CUSTOMER STATES THE LIGHT GLOVE IS TEARING AT THE SEAM. PATIENT INVOLVED, NO MEDICAL INTERVENTION.