MalfunctionFMC
NS-3600-B LITE GLOVE 1000/CASE
Received Sep 27, 2016 · Event occurred Sep 9, 2016
Report 9612030-2016-00466 · MDR key 5979709
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: 09/27/2016. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED. (B)(4) HAS CONTACTED THE CUSTOMER ON (B)(6) 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 REPORTED THAT THE 2 EACH LITE GLOVES IN THIS PACK IS RIPPED.