MalfunctionFMC
3611 LITE GLOVE
Received Oct 4, 2016
Report 9612030-2016-00493 · MDR key 5996494
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: 10/04/2016. 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. THE CUSTOMER STATES THAT THE PRODUCT IS TOO TIGHT AND SPLIT WHEN TRYING TO PLACE IT ON THE LAMP HANDLE.