inforMED
MalfunctionKXG

APPLICATOR,COTTON-TIP,WOOD,3,STRL

Received Aug 12, 2025 · Event occurred Jul 16, 2025

Report 1417592-2025-00380 · MDR key 22783684

Device

Generic name

Applicator,cotton-tip,wood,3,strl

Catalog number

MDS202105Z

Product problems

  • Material Integrity Problem
  • Material Integrity Problem

Patient

Not reported

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

IT WAS REPORTED THAT "THE SWAB SPLINTERED OFF IN THE PATIENT'S EYE". IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR. IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

Description of Event or Problem

SWAB "SPLINTERED OFF".