MalfunctionMBP
ACCELL EVO3C 10CC
Received Dec 3, 2013
Report 2090010-2013-00018 · MDR key 3603652
Device
Product problems
- Packaging Problem
Patient
Not reported
- No Patient Involvement
Narrative
Description of Event or Problem
IT WAS REPORTED "THE ACCELL EVO 3C 10CC BOX WAS SEALED BUT WHEN IT WAS OPENED, THE INNER POUCH WAS OPENED AT THE END. THE REP HAD ANOTHER UNIT ON THE SHELF AND USED THAT (OTHER) ONE W/O ISSUE." THERE WAS NO PT CONTACT WITH THE PRODUCT OR DELAY IN SURGERY REPORTED.
Additional Manufacturer Narrative
TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN REC'D FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.