inforMED
MalfunctionPUI

MEDLINE

Received Jun 16, 2026 · Event occurred May 28, 2026

Report 1417592-2026-02425 · MDR key 25519393

Device

Generic name

Field,sterile,tissue-poly-tiss,18x26

Catalog number

NON21003

Product problems

  • Tear, Rip or Hole in Device Packaging

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

IT WAS REPORTED THAT ONE OF THE DRAPES WAS RIPPED. 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.

Description of Event or Problem

IT WAS REPORTED THAT ONE OF THE DRAPES WAS RIPPED.