inforMED
InjuryKAM

FREEMAN FRONTAL SINUS STENT

Received Aug 29, 2001 · Event occurred Jul 26, 2001

Report 2025182-2001-00001 · MDR key 349872

Device

Generic name

Nasal Sinus Stent/sinus Cannula

Model number

NA

Catalog number

BE 1400

Lot number

620985

Product problems

  • Detachment Of Device Component
  • Tip breakage

Patient

11 YR

  • Surgical procedure
  • Foreign body, removal of

Narrative

Description of Event or Problem

- VERBALL DESCRIPTION FROM INITIAL REPORTER: "DEVICE WAS A STAINLESS STEEL INSERTER USED TO PLACE A NASAL STENT. THE TIP BROKE OFF THE INSERTER WHILE IN SITU. SURGICAL INTERVENTION WAS REQUIRED TO REMOVE THE INSERTER TIP. PT IS DOING WELL." - TAKEN FROM MEDWATCH FORM COMPLETED BY THE INITIAL REPORTER: "WHILE USING FRONTAL SINUS STENT INSTRUMENT, TIP OF INSTRUMENT DETACHED FROM INSTRUMENT AND LODGED IN SINUS. INCISION HAD TO BE MADE TO RETRIEVE TIP."