FDA Adverse Event Injury Summary report: N

CRAWFORD LACRIMAL INTUBATION SET

MDR report key: 251817 · Received November 19, 1999

Report

Report Number
251817
Event Type
Injury
Date Received
November 19, 1999
Date of Event
September 21, 1999
Report Date
October 14, 1999
Manufacturer
JEDMED INSTRUMENT CO.
Product Code
HNW
Adverse Event
Yes
Product Problem
Yes
Report Source
User Facility report
Reporter Location
TX, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

IN 1999 THE PT UNDERWENT UPPER AND LOWER PLASTIC REPAIR OF RIGHT-SIDED CANALICULI, NASAL LACRIMAL DUCT PROBING WITH INTUBATION, AND INFRACTURE OF THE MIDDLE TURBINATE. THREE ATTEMPTS WERE REQUIRED FOR CRAWFORD TUBE PLACEMENT, AS THE TUBES CONTINUED TO BREAK UPON PASSAGE. FINALLY, A TUBE WAS PASSED SUCCESSFULLY THROUGH THE CANALICULI. THE PT RETURNED TO SURGERY FOR THE SECOND STAGE OF THE PROCEDURE. AT THAT TIME, A PIECE OF THE LACRIMAL INTUBATION SET FROM THE PREVIOUS SURGERY WAS FOUND IN THE CANALICULI. THE PHYSICIAN REMOVED THE RETAINED PIECE OF TUBING AT THIS TIME.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 CRAWFORD LACRIMAL INTUBATION SET LACRIMAL INTUBATION SET HNW JEDMED INSTRUMENT CO. * *

Patients

Seq Age Sex Outcome Treatment
1 44 YR Required Intervention