MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC INSTANT HOT PACK; PACK, HOT OR COLD, DISPOSABLE

Device Problems Burst Container or Vessel (1074); Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/04/2022

Event Type  malfunction  

Event Description

Patient called out stating "the hot packs are running down my privates and leg" i arrived to the room with towels and wash cloths.The patient cleaned her right groin and thigh with a wet wash cloth then dried it with a towel.Patient denied any burning sensation or pain to the right groin or thigh.I did not notice any skin breakdown.I notified rn.I then attempted to activate a new hot pack (cardinal health) and it exploded.It got on the patient's shoe, the floor and my shirt and shoe.I cleaned the patient's shoe and the floor.I notified the charge nurse of the incident and central supply.I then removed all of the hot packs from the clean supply room placed them in a bag and notified central supply.Fda safety report id # (b)(4).

• Brand Name: INSTANT HOT PACK
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC
• MDR Report Key: 14675757
• MDR Text Key: 294030185
• Report Number: MW5110250
• Device Sequence Number: 2
• Product Code: IMD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/08/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/10/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Weight: 60 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American