inforMED
InjuryJAC

TOMOSPOT

Received May 6, 2019 · Event occurred Apr 18, 2019

Report 9021987-2019-00001 · MDR key 8582000

Device

Generic name

Scar Marker

Model number

783

Catalog number

783

Lot number

783.03221901

Product problems

  • Device Slipped

Patient

Not reported

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

A SCAR MARKER FELL OFF A PATIENT DURING A MAMMOGRAM. AS A RESULT, THE MAMMOGRAM WAS REPEATED.

Remedial action

  • Replace