inforMED
InjuryFCE

KENDALL SEAMLESS ENEMA BAG

Received Aug 11, 2011 · Event occurred Aug 9, 2011

Report 2423463 · MDR key 2423463

Device

Generic name

Enema Bag

Lot number

106682264

Product problems

  • Labelling, Instructions for Use or Training Problem
  • Device, or device fragments remain in patient
  • Use of Device Problem

Patient

86 YR

  • Device induced
  • Foreign body, removal of

Narrative

Description of Event or Problem

INSTRUCTIONS INADEQUATE. FAIL TO STATE BLUE PIECE MUST BE REMOVED BEFORE INSERTION OF TUBING IN PT.