InjuryJAC
A-SPOT
Received Dec 17, 2015 · Event occurred Nov 17, 2015
Report 9021987-2015-00006 · MDR key 5306038
Device
Generic name
Palpable Mass Marker
Manufacturer
Beekley CorporationModel number
651Catalog number
651
Lot number
651.09251402
Product problems
- Signal Artifact/Noise
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
A PALPABLE MASS MARKER MAY HAVE CAUSED ARTIFACT ON A MAMMOGRAM. AS A RESULT, THE MAMMOGRAM WAS REPEATED.
Remedial action
- Replace