MalfunctionFMC
3611 LITE GLOVE
Received Aug 31, 2016
Report 9612030-2016-00418 · MDR key 5919938
Device
Product problems
- Crack
- Torn Material
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
SUBMIT DATE: 08/31/2016. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED. MANSFIELD PRODUCT MONITORING HAS CONTACTED THE CUSTOMER ON 08/16/2016, 08/18/2016, AND 08/31/2016, TO DATE, NO RESPONSE HAS BEEN RECEIVED. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, THE REPORT WILL BE UPDATED.
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 REPORTS LIGHT HANDLE COVER HAD TEARS AND CRACKING IN IT BEFORE USE.