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

Model Number 11450-040B

Device Problems Material Rupture (1546); Unexpected Therapeutic Results (1631)

Patient Problems Chemical Exposure (2570); Superficial (First Degree) Burn (2685)

Event Date 06/07/2022

Event Type  Injury  

Event Description

Hot packs used for pain relief exploded when patient attempted to activate it, per instructions on package.The patient was not burned by the contents, as the contents only got on patient's bed and sheets.Fda safety report id# (b)(4).

• Brand Name: HOT PACK
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): CARDINAL HEALTH
• MDR Report Key: 15067042
• MDR Text Key: 296324593
• Report Number: MW5110975
• Device Sequence Number: 1
• 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: Nurse
• Type of Report: Initial
• Report Date: 07/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11450-040B
• Device Catalogue Number: 11450-040B
• Device Lot Number: V2C174
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1