Medline MDS138055Recalls & reported problems
Medline Industries, Inc. · PACK,COLD,STANDARD,OB-PAD,4.5X14.25 · Class 1
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00080196733715), received between Dec 5, 2019 and Sep 11, 2026 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Explosion” (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
- Explosion2
- Fluid/Blood Leak2
- Gel Leak1
- Leak/Splash1
- Material Split, Cut or Torn1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Red Eye(s)2
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 11, 2026Fluid/Blood Leak; Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50734310 ↗MalfunctionSep 10, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50717322 ↗MalfunctionSep 9, 2026Gel Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50692646 ↗MalfunctionAug 11, 2026Mechanical Problem
It was reported that we are getting quite a few without the activators in them. Like in the case I just opened, 6 of 24 did not contain them.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50208054 ↗MalfunctionMay 12, 2026Leak/Splash
ACCORDING TO THE CUSTOMER, "SHE USED THE PACK AT NIGHT AND WHEN SHE WOKE UP THE PACK WAS LEAKING. CUSTOMER STATED SHE FOLDED THE PACK AND PLACED IN HER UNDERWEAR. WHEN SHE WOKE UP SHE NOTICED THE ISSUE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25153426 ↗MalfunctionDec 5, 2019Explosion
IT WAS REPORTED THAT THE INSTANT HOT PACK EXPLODED UPON ACTIVATION BY PATIENT'S HUSBAND. THE PATIENT REQUIRED EYE IRRIGATION TO REMOVE INSTANT COLD PACK CONTENTS FROM HER EYES.
Patient problems: Red Eye(s)
MAUDE report 9416361 ↗MalfunctionDec 5, 2019Explosion
IT WAS REPORTED THAT THE PATIENT'S HUSBAND ACTIVATED THE COLD PACK AND IT EXPLODED. THE PATIENT'S HUSBAND REQUIRED EYE IRRIGATION.
Patient problems: Red Eye(s)
MAUDE report 9416168 ↗
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.