inforMED
InjuryNEU

SCOUT®

Received Jul 9, 2026 · Event occurred Jun 12, 2026

Report 2032338-2026-00006 · MDR key 25769223

Device

Generic name

Marker, Radiographic, Implantable

Catalog number

SSR75S-01/Q

Lot number

H3458285

Product problems

  • Adverse Event Without Identified Device or Use Problem

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

IT WAS REPORTED THAT THE SCOUT REFLECTOR WAS INSERTED THROUGH WIDE LOCAL EXCISION AND NO SIGNAL FROM THE SKIN OR TISSUE WAS REPORTED. THE EVENT NECESSITATED MEDICAL INTERVENTION BY A RADIOLOGIST WHO HAD TO RELOCALIZE USING AN ULTRASOUND.

Additional Manufacturer Narrative

THE SUSPECT DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE INVESTIGATION AND PRODUCT HISTORY REVIEW IS COMPLETE.