MalfunctionQDY
EVA TDC VITRECTOMY PACK VGPC INPUT 25G
Received Jan 4, 2019
Report 1222074-2019-00001 · MDR key 8218178
Device
Product problems
- Unsealed Device Packaging
Patient
Not reported
- No Information
- No Information
Narrative
Additional Manufacturer Narrative
THE PRODUCT IS RETURNED, INITIAL ANALYSIS TO DETERMINE THE NATURE AND ROOT CAUSE OF THE PACKAGING ISSUE IS IN PROGRESS. [(B)(4)].
Description of Event or Problem
POSSIBLE PACKAGING INTEGRITY ISSUE WHICH WAS DETECTED BEFORE USE.