MalfunctionMBP
ACCELL EVO3C 10CC
Received May 24, 2013
Report 2090010-2013-00004 · MDR key 3134388
Device
Product problems
- Unsealed Device Packaging
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
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.
Description of Event or Problem
IT WAS REPORTED "THE INNER STERILE PACKAGING ON THE PRODUCT WAS FOUND TO NOT BE COMPLETELY SEALED. ANOTHER BOX WAS AVAILABLE FOR USE IN THE SURGERY, THERE WAS NO DELAY IN THE SURGERY."