Medline MDS138010Recalls & reported problems
Medline Industries, Inc. · PACK,COLD,INSTANT,HEAVY-WT,JR,4.75X7 · Class 1
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10080196158577), received between Aug 16, 2023 and Aug 14, 2026 — classified as 1 injury, 5 malfunctions.
The most frequently reported specific device problem is “Burst Container or Vessel” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Burst Container or Vessel2
- Leak/Splash2
- Excessive Cooling1
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Burn(s)1
- Eye Irritation1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 14, 2026Burst Container or Vessel
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50258817 ↗MalfunctionAug 11, 2026Excessive Cooling
It was reported that the cold pack she was using caused a burn on her neck. Customer noticed a couple hours after using it has blistered.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50209714 ↗MalfunctionAug 10, 2026Leak/Splash
It was reported that "SHE RECIEVED A CASE OF THE ICE PACKS ALL DAMAMGED. WHEN FOLLOWING THE DIRECTION THEY LEAK AND BEADS FALL EVERYWHERE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50196288 ↗MalfunctionJul 3, 2026Leak/Splash
IT WAS REPORTED THAT ONE OF THE MEDLINE COLD PACKS LEAKED ON A PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25703341 ↗MalfunctionMay 5, 2026Material Integrity Problem
ACCORDING TO THE FACILITY, THERE WAS AN INCIDENT WITH THE HOT AND COLD PACK MDS138010 WHICH RESULTED IN A NURSE HAVING A REACTION AS THE PACK BUSTED.
Patient problems: Burn(s)
MAUDE report 25082931 ↗InjuryAug 16, 2023Burst Container or Vessel; Burst Container or Vessel
ICE PACK CONTENTS IN EYE REQUIRING INTERVENTION.
Patient problems: Eye Irritation
MAUDE report 17560220 ↗
Other PACK, HOT OR COLD, DISPOSABLE devices
- ThermaCare HeatWraps ThermaCare HeatWraps - Lower Back & HipPfizer Inc. · PACK, HOT OR COLD, DISPOSABLE196 reports
- NOVAPLUS V11460-010Cardinal Health 200, LLC · PACK, HOT OR COLD, DISPOSABLE1 recall16 reports
- CARDINAL HEALTH 11443-012BCardinal Health 200, LLC · PACK, HOT OR COLD, DISPOSABLE56 reports
- ThermaCare HeatWraps ThermaCare HeatWraps - Lower Back & HipPfizer Inc. · PACK, HOT OR COLD, DISPOSABLE37 reports
- ThermaCare HeatWraps ThermaCare HeatWraps - Neck, Wrist & ShoulderPfizer Inc. · PACK, HOT OR COLD, DISPOSABLE1 death31 reports
- CARDINAL HEALTH 11450-040Cardinal Health 200, LLC · PACK, HOT OR COLD, DISPOSABLE20 reports
- ThermaCare HeatWraps ThermaCare HeatWraps - Lower Back & HipPfizer Inc. · PACK, HOT OR COLD, DISPOSABLE14 reports
- Medline MDS139008Medline Industries, Inc. · PACK, HOT OR COLD, DISPOSABLE13 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.