MalfunctionJAC
CT SPOTS LINE
Received Aug 29, 2012 · Event occurred Jul 16, 2012
Report 9021987-2012-00013 · MDR key 2726430
Device
Generic name
Skin Markers
Manufacturer
Beekley CorporationModel number
I-118Catalog number
118
Lot number
I-118.07111201
Product problems
- Component Missing
Patient
Not reported
- No Patient Involvement
Narrative
Description of Event or Problem
PRODUCT DID NOT HAVE LABELING AFFIXED TO THE BOX.
Additional Manufacturer Narrative
DISTRIBUTOR WAS SENT LABELS TO AFFIX TO THE PACKAGING BEFORE RE-SALE.
Remedial action
- Relabeling