CP+S INSTANT COLD COMPRESS

Description of Event or Problem

A (B)(6) BOY WAS PLAYING BASKETBALL AT A (B)(6) GYM WHEN THE BALL HIT HIM IN THE FACE NEAR THE EYE. THE PERSON RESPONSIBLE FOR THE CHILD AT THE TIME ACTIVATED AN INSTANT COLD COMPRESS (ICE PACK) AND INSTRUCTED THE CHILD TO HOLD IT ON HIS EYE/FACE. THE ICE PACK WAS REPORTED TO HAVE A SMALL HOLD IN IT WHICH CAUSED IT TO LEAK ONTO THE FACE OF THE BOY AND IN HIS EYE. THE PERSON RESPONSIBLE FOR THE CHILD TOOK HIM INO THE BATHROOM WHERE THEY FLUSHED THE EYE AND FACE WITH WATER. THE PARENTS WERE NOTIFIED IMMEDIATELY AND IT WAS SUGGESTED THAT THE BOY VISIT A PHYSICIAN. THE PARENTS TOOK THE CHILD TO CHILDREN'S URGENT CARE IN (B)(6) WHERE EYE DROPS WERE GIVEN AND THE CHILD WAS SENT HOME.

Additional Manufacturer Narrative

EMPLOY AND ABILITY, INC. IS THE MFR FOR THE CP AND S BRAND INSTANT COLD COMPRESS. THE COLD COMPRESS THAT LEAKED WAS THROWN AWAYA BY THE END USER AT THE TIME OF THE INCIDENT THEREFORE, THE NATURE AS TO WHAT CAUSED THE LEAK IS UNKNOWN. THERE WAS ALSO NO LOT NUMBER SUPPLIED AT THE TIME THIS REPORT WAS GENERATED. ON THE BACK OF THE COLD COMPRESS THERE ARE WARNINGS AND THE SIXTH WARNING CLEARLY STATES TO CHECK FOR LEAKS BEFORE USE. DISCARD IF PUNCTURED OR LEAKING. THIS WAS NOT PERFORMED BY THE END USER.