inforMED
MalfunctionIMF

INSTANT COLD PACK

Received Nov 21, 2001

Report 1423507-2001-00277 · MDR key 361937

Device

Generic name

Cold Pack

Model number

10104

Catalog number

10104

Lot number

V1J045

Product problems

  • Material Rupture

Patient

UNKNOWN

  • Blurred Vision
  • Burning Sensation
  • Other (for use when an appropriate patient code cannot be identified)
  • Therapy/non-surgical treatment, additional
  • Chemical Exposure
  • Treatment with medication(s)

Narrative

Description of Event or Problem

THE PACK RUPTURED AS THEY WERE ACTIVATING IT AND THE SOLUTION GOT INTO THE EYES AND SKIN OF THE CLINICIAN. SPOKE WITH STAFF WHO STATED THE EMPLOYEE IMMEDIATELY WASHED THE PRODUCT CONTENTS OFF OF THE SKIN AND RINSED THE EYES. EMPLOYEE EXPERIENCED BLURRED VISION, BURNING SENSATION AND WATERING OF EYES. EMPLOYEE WENT TO A PHYSICIAN, WHO PRESCRIBED EYE DROPS. EMPLOYEE IS DOING WELL AT THIS TIME AND HAS EXPERIENCED NO FURTHER PROBLEMS.