InjuryJAC
TOMOSPOT AND V-SPOT
Received Dec 18, 2024 · Event occurred Dec 4, 2024
Report 9021987-2024-00004 · MDR key 20967399
Device
Generic name
System, X-ray, Film Marking, Radiographic
Manufacturer
Beekley CorporationCatalog number
782 AND 703
Product problems
- Adverse Event Without Identified Device or Use Problem
- Insufficient Device Problem Information
- Adverse Event Without Identified Device or Use Problem
- Insufficient Device Problem Information
Patient
NA · Unknown
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
TOMOSPOT AND V-SPOT SKIN MARKERS MAY HAVE CAUSED IMAGING ARTIFACT DURING A MAMMOGRAM, THEREFORE THE MAMMOGRAM WAS REPEATED.