MalfunctionFAT
INFRAVISION 56 FR. ESOPHAGEAL KIT (5BX)
Received Apr 27, 2010 · Event occurred Apr 14, 2010
Report 2936485-2010-00343 · MDR key 1675714
Device
Product problems
- Device Dislodged or Dislocated
Patient
UNK
- No Information
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THERE WERE TWO INSTANCES WHERE PATIENTS COUGHED UP THE SHEATH OF THE E-KIT. NO OTHER DETAILS WERE AVAILABLE AT THIS TIME.
Additional Manufacturer Narrative
ADD'L INFO WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.