CARDINAL HEALTH 30104Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00630140039839), received between Apr 26, 2018 and Sep 8, 2023 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (6 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2023Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED HEAT PACK WAS PLACED DIRECTLY ON SKIN OF LOWER BACK AND CAUSED 2ND DEGREE BURN. NO MEDICATION WAS GIVEN AS PATIENT REPORTED THE ISSUE TO THE STAFF AFTER DISCHARGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17716523 ↗
• MalfunctionAug 18, 2023Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER STATED PATIENT CARE TECH WENT TO SQUEEZE HOT PACK TO ACTIVATE FOR PATIENT. HOT PACK BURST, COVERING EMPLOYEE EYES IN THE FLUID FROM THE PACK. THE HOT PACK WAS DISCARDED. NO ADVERSE INJURY TO EMPLOYEE AND NO TREATMENT GIVEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17580548 ↗
• MalfunctionDec 20, 2022Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED A LEAKING HOT PACK. BASED ON THE FOLLOW UP FROM THE CUSTOMER NURSE REPORTED WHEN THE HOT PACK WAS SQUEEZED IT LEAKED ON HER. THE LEAKAGE TOUCHED THE CLINICIAN ON THE TOP OF HER LEG AND ON HER LAP. THE CLINICIAN IS FINE WITH NO REPORTED ISSUES AFTER REMOVING PACK MATERIAL BY CHANGING PANTS AND BY WASHING HER SKIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16015106 ↗
• MalfunctionSep 23, 2022Burst Container or Vessel; Burst Container or Vessel

  CONSUMER REPORTED THAT A CARDINAL HEALTH HOT PACK THAT SHE RECEIVED LEAKED ON HER DURING HER ATTEMPT TO USE PRODUCT. THERE HAS BEEN NO INJURY REPORTED. NO FURTHER INFORMATION, CLINICAL DATA, OR PATIENT DEMOGRAPHICS WERE PROVIDED WHEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15471940 ↗
• MalfunctionDec 22, 2021Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED THAT THEY RECEIVED CARDINAL HEALTH HOT PACKS THAT BURST DURING TRANSPORT WHILE IN THE CARDINAL HEALTH TOTES. THERE WAS NO INJURY REPORTED AND NO ONE AT THE FACILITY WAS EXPOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13060521 ↗
• InjuryJun 25, 2019Burst Container or Vessel

  BASED ON INFORMATION RECEIVED FROM THE CUSTOMER, WHILE SORTING THROUGH A CASE OF HOT PACKS, ONE BURST ONTO AN EMPLOYEE. SHE WAS LIGHTLY SQUEEZING THEM TO SEE IF THEY WERE HARD OR USABLE. SHE LIGHTLY SQUEEZED THE PACKAGE AND IT BURST IN HER HAND AND SPLATTERED ONTO HER FOREARM. THE EMPLOYEE REPORTEDLY RECEIVED A 1ST DEGREE BURN TO HER FOREARM, THAT HEALED A FEW DAYS LATER. IT WAS REPORTED THAT SHE WAS ORIGINALLY SEEN BY OCCUPATIONAL HEALTH, WHERE SHE WAS FLUSHED WITH SOAP AND WATER. SHE WAS THEN TREATED AT THE URGENT CARE CENTER IN NORFOLK. A SILVADENE DRESSING WAS APPLIED BY THE DOCTOR.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 8732244 ↗
• InjuryApr 26, 2018Improper or Incorrect Procedure or Method

  BASED ON A MEDWATCH FILED BY THE CUSTOMER AND INTERACTION WITH THE CUSTOMER, IT WAS REPORTED TWO HOT PACKS WERE APPLIED FOR PATIENT COMFORT. THE TWO HOT PACKS WERE HANDED TO THE PATIENT. REPORTEDLY, THE PATIENT FELL ASLEEP WITH THEM UNDER HER, CAUSING PARTIAL THICKNESS BURNS L 17CM X W 15CM. THE PATIENT REQUIRED MINOR TREATMENT FROM WOUND CARE AND BURN TEAM. IT WAS RECOMMENDED DAILY WOUND CARE BY RN TEAM, PRE-MEDICATION AS NEEDED (PRN) BEFORE WOUND CARE, CLEAN WITH 4% CHLORHEXIDINE WIPES OR JOHNSON AND JOHNSON BABY SOAP WITH WATER, PAD DRY, APPLY THIN LAYER OF SANTYL/ COLLAGENASE OVER WOUND, COVER WITH MEPILEX LITE DRESSING AND SUPPORT WITH TAPE.

  Patient problems: Burn, Thermal

  MAUDE report 7464968 ↗