TELFA
Received Jun 10, 2026 · Event occurred Apr 30, 2026
Report 0001221144-2026-00001 · MDR key 25452540
Device
Product problems
- No Apparent Adverse Event
Patient
66 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
DESCRIBE THE EVENT OR PROBLEM: COTTONOID COUNT WAS OFF WITH CLOSING COUNT. WENT THROUGH TRASH AND STERILE FIELD MULTIPLE TIMES. SURGEON REOPENED INCISION FOR A RELOOK. TOOK A C ARM PICTURE WITH NOTHING DETECTED. CALLED XR TECH FOR FLATPLATE IMAGE, AGAIN NOTHING WAS DETECTED. PLACED A COTTONOID ON PATIENT'S SKIN TO SEE IF XR WAS PICKING UP THE COTTONOID AT ALL AND IT WAS NOT VISIBLE IN THE IMAGE. PACKAGE STATES THESE COTTONOID STINGS ARE BARRIUM IMPREGNATED SO THEY SHOULD BE DETECTABLE IN XRAY. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? NOT KNOWN. WHAT PROBLEM DID THE USER HAVE: OTHER. THERAPIES BEING USED ON THE PATIENT AT THE TIME OF THE EVENT THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT: NOT KNOWN.