FDA Adverse Event Other Summary report: N

CURITY ULTRAMER CATHETER

MDR report key: 277869 · Received May 11, 2000

Report

Report Number
9611712-2000-00001
Event Type
Other
Date Received
May 11, 2000
Date of Event
April 5, 2000
Report Date
May 11, 2000
Manufacturer
THE KENDALL CO
Product Code
KOD
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
NY, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

ON 4/5/2000 AT HOSP WHEN THE 1616 FOLEY CATHETER WAS REMOVED FROM THE PT, THE LATEX BALLOON WAS MISSING. DR HAD TO RETRIEVE BALLOON FROM PT. NO PERMANENT INJURY RESULTED. KENDALL'S QUALITY ASSURANCE DEPT WAS NOTIFIED OF THIS EVENT ON 4/12/2000.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 CURITY ULTRAMER CATHETER 16 FRENCH FOLEY CATHETER KOD THE KENDALL CO * *

Patients

Seq Age Sex Outcome Treatment
1 * Required Intervention