inforMED
InjuryIME

RITE AID PAIN RELIEF INSTANT COLD PACK

Received Jul 31, 2018 · Event occurred Apr 20, 2014

Report 3012316249-2018-00046 · MDR key 7735749

Device

Generic name

Cold Pack

Lot number

130413

Product problems

  • Leak/Splash
  • Leak/Splash

Patient

Not reported

  • Full thickness (Third Degree) Burn
  • Full thickness (Third Degree) Burn

Narrative

Description of Event or Problem

RITE AID PAIN RELIEF INSTANT COLD PACK IS THE PRODUCT DESCRIPTION, ITEM NUMBER UNKNOWN. LOT #: 130413. ON (B)(6) 2014 THE END-USER PUT ON LOWER BACK FOR 1/2 HOUR THEN REMOVED THEN PUT ANOTHER ONE ON 6 HOURS LATER FOR 30 MINUTES. UNKNOWN IF PRODUCT WAS BROKEN OR NOT. LATER THAT EVENING DEVELOPED BLISTERS ON HIS BACK WHERE THE COLD PACK HAD BEEN APPLIED. END-USER'S BLISTERS THEN POPPED AND APPEARED INFLAMED OR INFECTED AND ON (B)(6), PRESENTED TO HIS PRIMARY CARE PHYSICIAN FOR DIAGNOSIS AND TREATMENT OF RUPTURED BLISTERS. AT FIRST IT WAS THOUGHT THAT THE BLISTERS WERE THE RESULT OF A FROST BITE, TYPE INJURY CAUSED BY THE COLD PACK, CONSUMER NOT KNOWING THAT THE COLD PACK HAD ACTUALLY LEAKED ONTO HIS SKIN, BUT WERE LATER MEDICALLY DETERMINED TO BE A CHEMICAL BURN CAUSE BY FLUID THAT HAD UNNOTICEABLY ESCAPED FROM INSIDE THE COLD PACK DURING ITS USE, THEREBY COMING INTO CONTACT WITH CONSUMER'S SKIN AND CAUSING THE CHEMICAL BURNS TO CONSUMER'S LOWER BACK. CHEMICAL THIRD DEGREE BURN INJURY WOUNDS BECAME INFECTED AND HAD TREATMENT AT AN ADVANCED WOUND CARE CENTER.