inforMED
MalfunctionMCZ

MEDLINE

Received Jul 1, 2026 · Event occurred Jun 3, 2026

Report 3004122598-2026-00043 · MDR key 25686406

Device

Generic name

Tray,suture Removal,metal Iris,forceps

Catalog number

DYND70900H

Lot number

26CBS231

Product problems

  • Unsealed Device Packaging

Patient

Not reported

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

IT WAS REPORTED THAT THE PACKAGE WAS OPEN WITH GAUZE STICKING OUT.

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE PACKAGE WAS OPEN WITH GAUZE STICKING OUT. THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, OR FOLLOW UP CARE. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. IN AN ABUNDANCE OF CAUTION, THIS IS A REPORTABLE EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE REOPENED AND REEVALUATED.